GraftTech PULL000217

GUDID 03760154006149

GraftTech® preparation station including brackets, to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruction.

S.B.M

Tendon/ligament graft preparation station
Primary Device ID03760154006149
NIH Device Record Key99bf4a64-d1f5-48a1-8d38-9de5146e04b3
Commercial Distribution StatusIn Commercial Distribution
Brand NameGraftTech
Version Model NumberGraft preparation station
Catalog NumberPULL000217
Company DUNS772462123
Company NameS.B.M
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS103760154006149 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


[03760154006149]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-28
Device Publish Date2023-12-20

On-Brand Devices [GraftTech]

03760154006149GraftTech® preparation station including brackets, to be used with PULLUP and BT LOOP adjustabl
03760154006200GraftTech cleaning and sterilization basket.
03760154006194Complete graft preparation station set intended to be used to prepare the graft + PULLUP constru

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