Small Tear replaces Stryker® TM5511RS

GUDID 24053613294526

Gebr. Brasseler GmbH & Co. KG

Bone file/rasp, reciprocating, single-use
Primary Device ID24053613294526
NIH Device Record Key94d55451-2cbe-4e77-a6d2-652db863719b
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmall Tear replaces Stryker®
Version Model NumberTM5511RS
Catalog NumberTM5511RS
Company DUNS317409001
Company NameGebr. Brasseler GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS114053613294529 [Primary]
GS124053613294526 [Package]
Contains: 14053613294529
Package: [1 Units]
In Commercial Distribution

FDA Product Code

GFABlade, Saw, General & Plastic Surgery, Surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-08-05
Device Publish Date2025-07-28

Devices Manufactured by Gebr. Brasseler GmbH & Co. KG

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24053613293345 - R-20 Reciprocating Saw Blade2025-08-06
24053613293352 - R-30 Reciprocating Saw Blade2025-08-06
24053613293369 - R-40 Reciprocating Saw Blade2025-08-06
24053613293376 - S-6 Oscillating Sagittal Saw Blade2025-08-06
24053613293383 - S-10 Oscillating Sagittal Saw Blade2025-08-06
24053613294526 - Small Tear replaces Stryker®2025-08-05
24053613294526 - Small Tear replaces Stryker®2025-08-05
24053613290979 - Brophy, Round shank2025-08-04

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