6982-3-014

GUDID 07613153182979

Soft tissue retainer for 14mm Staple

Stryker Trauma GmbH

Orthopaedic implantation sleeve, reusable

Primary Device ID	07613153182979
NIH Device Record Key	9c94938b-9117-4dad-86cd-58c69f9246ad
Commercial Distribution Status	In Commercial Distribution
Version Model Number	6982-3-014
Catalog Number	6982-3-014
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	true
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	07613153182979 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K822943

FDA Product Code

JDR	STAPLE, FIXATION, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

Moist Heat or Steam Sterilization

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

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[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

Moist Heat or Steam Sterilization

[07613153182979]

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[07613153182979]

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[07613153182979]

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[07613153182979]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

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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