ACCY 3550S-02 STIMLOC DISPSBL SCREWDRVER Medical Device Identification

GUDID 00763000210205

ACCY 3550S-02 STIMLOC DISPSBL SCREWDRVER

MEDTRONIC, INC.

Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use Neurosurgical procedure kit, non-medicated, single-use

Primary Device ID	00763000210205
NIH Device Record Key	528400d6-5989-46ea-bae4-877e9e3a40e2
Commercial Distribution Status	In Commercial Distribution
Version Model Number	3550S-02
Company DUNS	796986144
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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00763000210205 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K001096

FDA Product Code

GXR	COVER, BURR HOLE

Sterilization

Steralize Prior To Use	false
Device Is Sterile	true

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2021-11-01
Device Publish Date	2021-10-24

Devices Manufactured by MEDTRONIC, INC.

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00763000953614 - NA	2024-05-31 CUSTOM PACK HY0A20R46 CHRST NN
00763000953621 - NA	2024-05-31 CUSTOM PACK BB11Q49R11 3/8 EC
00763000953638 - NA	2024-05-31 CUSTOM PACK BB12A45R1 SMALL LOOP
00763000953645 - NA	2024-05-31 CUSTOM PACK BB12A44R2 LRG AV LOOP
20763000953663 - NA	2024-05-31 CUSTOM PACK BB12G60R 2PK 2PK CHRST TBL
00763000953676 - NA	2024-05-31 CUSTOM PACK BB7B00R26 UW CMAG PK