← Back to catalogue

GraftTech

FDA UDI

Class I (US FDA UDI)

by S.b.m

Identity

Trade Name
GraftTech FDA UDI
Generic Name
Tendon/ligament graft preparation station FDA UDI
Device Name
GraftTech® preparation station including brackets, to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruction. FDA UDI
Model / Reference
Graft preparation station FDA UDI
Description
GraftTech® preparation station including brackets, to be used with PULLUP and BT LOOP adjustable fixation devices for ACL reconstruction. FDA UDI

Identifiers

Catalog Number
PULL000217 FDA UDI
Primary DI / UDI-DI
03760154006149 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Tendon/ligament graft preparation station FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Tendon/ligament graft preparation station

GraftTech by S.b.m — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tendon/ligament graft preparation station.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
S.b.m

Sources (1)

  • FDA UDI 99bf4a64-d1f5-48a1-8d38-9de5146e04b3 34 fields · synced May 30, 2026