1320-8201

GUDID 07613327298192

ADAPT Gamma3 DTS Clip

Stryker Trauma GmbH

Medical image management system

Primary Device ID	07613327298192
NIH Device Record Key	d7d7d5ef-ee41-4332-85e2-018337a03abc
Commercial Distribution Status	In Commercial Distribution
Version Model Number	1320-8201
Catalog Number	1320-8201
Company DUNS	330211587
Company Name	Stryker Trauma GmbH
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613327298192 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K173946

FDA Product Code

OLO	Orthopedic stereotaxic instrument

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[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

[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 Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2018-10-15
Device Publish Date	2018-09-14

Devices Manufactured by Stryker Trauma GmbH

07613327376210 - T2 ALPHA	2023-12-21 Locking Scalpel
07613327361797 - T2 ALPHA	2023-06-02 Guide Wire with Ruler Tube
07613327361803 - T2 ALPHA	2023-06-02 Guide Wire with Ruler Tube
07613327406153 - T2 ALPHA	2023-06-02 Guide Wire
07613327406184 - T2 ALPHA	2023-06-02 Guide Wire
07613327095548 - T2	2022-05-05 Tibia System Magnetic Trigger
07613153179443 - T2	2022-02-08 Locking Screw, Fully Threaded
04546540202475 - T2	2022-02-04 Locking Screw, Fully Threaded

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