PlasmaBlade(TM)

GUDID 00643169617162

PLASMABLADE PS210-030S-SP LOCK MPSS

MEDTRONIC, INC.

Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use Open-surgery electrosurgical handpiece/electrode, monopolar, single-use

Primary Device ID	00643169617162
NIH Device Record Key	15444088-a80d-4726-bb75-0b11b8d269a6
Commercial Distribution Status	In Commercial Distribution
Brand Name	PlasmaBlade(TM)
Version Model Number	PS210-030S-SP
Company DUNS	030200852
Company Name	MEDTRONIC, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com
Phone	+1(800)633-8766
Email	Corporate.UDI@medtronic.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00643169617162 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093695

FDA Product Code

GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2019-02-07
Device Publish Date	2016-04-25

On-Brand Devices [PlasmaBlade(TM)]

00643169617193	PLASMABLADE PS200-040-SP 4.0 MPSS
00643169617186	PLASMABLADE PS200-040 EA 4.0 PINK MPSS
00643169617179	PLASMABLADE PS200-040 4.0 MPSS
00643169617162	PLASMABLADE PS210-030S-SP LOCK MPSS
00643169617155	PLASMABLADE PS210-030S PINK LOCK MPSS
00643169617148	PLASMABLADE PS210-030S 3.0S LOCK MPSS
00643169617131	PLASMABLADE PS210-030P PLUS LOCK MPSS
20643169175130	PLASMABLADE PS300-003 ADENOID 4PK
20643169175123	PLASMABLADE PS200-001 4PK NEEDLE
20643169175116	PLASMABLADE PS300-002 TNA 4PK
20643169175109	PLASMABLADE PS300-001 TONSIL 4PK
20643169175093	PLASMABLADE PS300-004 SUCT COAG BLA 16PK