316440

GUDID H9803164400

1.0MM DRILL BIT/STRYKER J-LTCH WITH 12MM STOP/44.5MM

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable
Primary Device IDH9803164400
NIH Device Record Keyef89c1d4-8295-404d-b1c9-f35c6a83a3f0
Commercial Distribution StatusIn Commercial Distribution
Version Model Number316.440
Catalog Number316440
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exempttrue
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
GS110887587038001 [Primary]
HIBCCH9803164400 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


[H9803164400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-11-22
Device Publish Date2018-09-21

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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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