31623

GUDID H980316230

0.70MM DRILL BIT/MINI QC WITH 3MM STOP/44.5MM

SYNTHES (U.S.A.) LP

Fluted surgical drill bit, reusable
Primary Device IDH980316230
NIH Device Record Key6a18ba70-70fe-4c93-80c3-f69967fb05a2
Commercial Distribution StatusIn Commercial Distribution
Version Model Number316.23
Catalog Number31623
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
GS110887587037875 [Primary]
HIBCCH980316230 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ERLDRILL, SURGICAL, ENT (ELECTRIC OR PNEUMATIC) INCLUDING HANDPIECE

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

Moist Heat or Steam Sterilization


[H980316230]

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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