SD03503714

GUDID 10887587076782

1.5MM TROCAR DRILL BIT J-LATCH W/ 14MM STOP/100MM

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable
Primary Device ID10887587076782
NIH Device Record Keyfef592cf-4030-4318-8719-eb0e3f5941d9
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD03.503.714
Catalog NumberSD03503714
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
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
GS110887587076782 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


[10887587076782]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-22
Device Publish Date2021-07-14

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

10886982293060 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
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

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.