03000211S

GUDID H98003000211S0

BURR CONICAL LENGTH 28MM Ø 6.0MM W/J-LATCH COUPLING

SYNTHES (U.S.A.) LP

Orthopaedic bur, reusable
Primary Device IDH98003000211S0
NIH Device Record Key5d6352fa-46fd-450b-b667-699ef9f40419
Commercial Distribution StatusIn Commercial Distribution
Version Model Number03.000.211S
Catalog Number03000211S
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
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 Datefalse
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
GS110887587009100 [Primary]
HIBCCH98003000211S0 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-06-30

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10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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