Guide Pin Kit 2024-0003

GUDID 24053613292539

Gebr. Brasseler GmbH & Co. KG

Orthopaedic intraoperative positioning pin, single-use
Primary Device ID24053613292539
NIH Device Record Key86de46ea-f1ca-4a26-931d-f0dee5ca692c
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Pin Kit
Version Model Number2024-0003
Catalog Number2024-0003
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
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 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
GS114053613292532 [Primary]
GS124053613292539 [Package]
Contains: 14053613292532
Package: [1 Units]
In Commercial Distribution

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 Date2025-02-18
Device Publish Date2025-02-10

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

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