28282

GUDID H679282820

BONE STAPLE 24MM X 25MM

Synthes GmbH

Orthopaedic bone staple, non-adjustable
Primary Device IDH679282820
NIH Device Record Keyb6480870-33be-46b9-b9dd-e5a33b97cace
Commercial Distribution StatusIn Commercial Distribution
Version Model Number282.82
Catalog Number28282
Company DUNS486711679
Company NameSynthes GmbH
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982179722 [Primary]
HIBCCH679282820 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDRSTAPLE, FIXATION, BONE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


[H679282820]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-07-14
Device Publish Date2015-09-14

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10886982350152 - NA2025-07-24 5TH MET WIRE GUIDE
10886982350428 - NA2025-07-24 TENS BENDING EXTRACTOR
10886982348326 - NA2025-07-08 SCREW RACK 3.0 & 4.0
10887587078434 - NA2025-07-03 REDUCTION FORCEPS W/ POINTS
10886982343994 - NA2025-07-01 Ø14MM HOLLOW REAMER - FRN

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