SD316440

GUDID H980SD3164400

1.0MM DRILL BIT/STRYKER J-LTCH WITH 3MM STOP/44.5MM

Synthes GmbH

Fluted surgical drill bit, reusable
Primary Device IDH980SD3164400
NIH Device Record Keyb8632f94-3663-495a-b920-d28cfdf288d2
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberSD316.440
Catalog NumberSD316440
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 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

Device Identifiers

Device Issuing AgencyDevice ID
GS110887587002378 [Primary]
HIBCCH980SD3164400 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZIDRILL, BONE, POWERED

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


[H980SD3164400]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-07-25
Device Publish Date2022-07-15

Devices Manufactured by Synthes GmbH

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H6794089050 - NA2025-02-20 7.3MM TI CANNULATED SCREW 16MM THREAD/105MM
07612334285515 - VOLT2024-12-19 VOLT(TM) PROX HUM IMP & INSTR 1 HIGH 3/3 WIDTH ALUM TRAY
10886982346896 - MAXFRAME2024-12-17 MAXFRAME AUTOSTRUT (TM) SOFTWARE
10886982347572 - NA2024-12-11 RFN-ADVANCED POLYMER INLAY STERILE
10886982330994 - VOLT2024-11-22 2.0MM VOLT(TM) ADAPTION PLATE 12H/65MM
07612334260079 - KINCISE2024-11-08 KINCISE(TM) SYSTEM SURGICAL HANDPIECE CASE
07612334268587 - KINCISE2024-11-08 KINCISE(TM) SYSTEM STERILIZATION CASE LID

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