395902

GUDID H6793959020

1.25MM/1.6MM PROTECTION SLEEVE

SYNTHES (U.S.A.) LP

Surgical drill guide, reusable
Primary Device IDH6793959020
NIH Device Record Key357a7edd-27e1-440f-a69d-df7ba3ef0c06
Commercial Distribution StatusIn Commercial Distribution
Version Model Number395.902
Catalog Number395902
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 Usefalse
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
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
GS110886982200884 [Primary]
HIBCCH6793959020 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


[H6793959020]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2020-04-06
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

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10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

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