Guide Screw PC3548

GUDID 24053613285951

Guide Screw Ø 3,20mm

Gebr. Brasseler GmbH & Co. KG

Intraoperative orthopaedic bone pin/screw, single-use
Primary Device ID24053613285951
NIH Device Record Keyc17321c7-a0c8-43a0-94c7-89d1b2b7e144
Commercial Distribution StatusIn Commercial Distribution
Brand NameGuide Screw
Version Model NumberPC3548
Catalog NumberPC3548
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 Batchfalse
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
GS114053613285954 [Primary]
GS124053613285951 [Package]
Contains: 14053613285954
Package: [2 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 Date2023-08-01
Device Publish Date2023-07-24

On-Brand Devices [Guide Screw]

24053613285951Guide Screw Ø 3,20mm
24053613285920Guide Screw Ø 3,20mm
24053613292119HTZ-2P-035-33
24053613292034HTZ-2P-025-25
24053613292027HTZ-2P-041-00
24053613292010HTZ-2P-040-48
24053613292003HTZ-2P-040-33
24053613291921HTD-4P-02-302
24053613291914HTD-4P-02-303

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