LOOP ® SPINAL SYSTEM

GUDID 00643169241855

INSERTER 2570002 LOOP INSERTER TUBE

MEDTRONIC SOFAMOR DANEK, INC.

Orthopaedic implant inserter/extractor, reusable Orthopaedic implant inserter/extractor, reusable
Primary Device ID00643169241855
NIH Device Record Key8b006cc4-a269-4dc1-bd1d-2de2b2c2f3ce
Commercial Distribution StatusIn Commercial Distribution
Brand NameLOOP ® SPINAL SYSTEM
Version Model Number2570002
Company DUNS830350380
Company NameMEDTRONIC SOFAMOR DANEK, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
GS100643169241855 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00643169241855]

Moist Heat or Steam Sterilization

[00643169241855]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2016-03-16

On-Brand Devices [LOOP ® SPINAL SYSTEM]

00643169398771ADAPTER 25700211 CAP
00643169398764INSERTER 25700021 TUBE
00643169398757TRIAL 25700061 IMPACTOR
00643169241855INSERTER 2570002 LOOP INSERTER TUBE

Trademark Results [LOOP]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LOOP
LOOP
98525395 not registered Live/Pending
LOOP BV
2024-04-29
LOOP
LOOP
98517864 not registered Live/Pending
ReFill LLC
2024-04-24
LOOP
LOOP
98509549 not registered Live/Pending
Global Apparel Partners, Inc.
2024-04-19
LOOP
LOOP
98373579 not registered Live/Pending
GET LBDO PTY LTD
2024-01-24
LOOP
LOOP
98319015 not registered Live/Pending
LOOP Worker Wellness, LLC
2023-12-18
LOOP
LOOP
98318997 not registered Live/Pending
LOOP Worker Wellness, LLC
2023-12-18
LOOP
LOOP
98288167 not registered Live/Pending
Baltimore Air Coil, Inc.
2023-11-28
LOOP
LOOP
98129367 not registered Live/Pending
Liu Meiyun
2023-08-11
LOOP
LOOP
98012653 not registered Live/Pending
Weinan Wins Future Technology Co., Ltd.
2023-05-25
LOOP
LOOP
98006904 not registered Live/Pending
KIDS MENTORING L.O.O.P. LTD
2023-05-22
LOOP
LOOP
97707809 not registered Live/Pending
AU Energy LLC
2022-12-07
LOOP
LOOP
97550450 not registered Live/Pending
Oxley, Nicholas Andrew
2022-08-16
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.