1320-8201

GUDID 07613327298192

ADAPT Gamma3 DTS Clip

Stryker Trauma GmbH

Medical image management system
Primary Device ID07613327298192
NIH Device Record Keyd7d7d5ef-ee41-4332-85e2-018337a03abc
Commercial Distribution StatusIn Commercial Distribution
Version Model Number1320-8201
Catalog Number1320-8201
Company DUNS330211587
Company NameStryker Trauma 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

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327298192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic stereotaxic instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


[07613327298192]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-15
Device Publish Date2018-09-14

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07613327361797 - T2 ALPHA2023-06-02 Guide Wire with Ruler Tube
07613327361803 - T2 ALPHA2023-06-02 Guide Wire with Ruler Tube
07613327406153 - T2 ALPHA2023-06-02 Guide Wire
07613327406184 - T2 ALPHA2023-06-02 Guide Wire
07613327095548 - T22022-05-05 Tibia System Magnetic Trigger
07613153179443 - T22022-02-08 Locking Screw, Fully Threaded
04546540202475 - T22022-02-04 Locking Screw, Fully Threaded

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