GUIDE SCREW Ø3,2X48,5 STE GS903.048.032 STE

GUDID 84053613287711

Gebr. Brasseler GmbH & Co. KG

Orthopaedic bone pin, non-bioabsorbable
Primary Device ID84053613287711
NIH Device Record Key1351f9c4-a324-495a-a25f-993b7889841b
Commercial Distribution StatusIn Commercial Distribution
Brand NameGUIDE SCREW Ø3,2X48,5 STE
Version Model NumberGS903.048.032 STE.YT
Catalog NumberGS903.048.032 STE
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
Device Count2
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS114053613287712 [Primary]
GS184053613287711 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-25
Device Publish Date2023-12-15

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

24053613289980 - Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290016 - Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290023 - Competitive Flared Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290054 - Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290177 - Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290184 - Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290207 - Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19
24053613290214 - Competitive Oscillating Saw Blade for ConMed®/Linvatec® Hall®2024-11-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.