N/A 390.051

GUDID 00885825020613

Adjustable Clamp

STRYKER SUSTAINABILITY SOLUTIONS, INC.

External orthopaedic fixation system reprocessed component
Primary Device ID00885825020613
NIH Device Record Key09895f88-3611-4d26-9c82-eacae6aaedaa
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberN/A
Catalog Number390.051
Company DUNS020198912
Company NameSTRYKER SUSTAINABILITY SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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(888)888-3433
EmailRegulatoryAffairs2@stryker.com
Phone+1(888)888-3433
EmailRegulatoryAffairs2@stryker.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100885825020613 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTTAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885825020613]

Moist Heat or Steam Sterilization


[00885825020613]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

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