StitchStand

FDA UDI

Class I (US FDA UDI)

by Winter Innovations, Inc.

Identity

Trade Name: StitchStand FDA UDI
Generic Name: Tendon/ligament graft preparation station FDA UDI
Device Name: StitchStand Graft Preparation Set FDA UDI
Model / Reference: SS-100 FDA UDI
Description: StitchStand Graft Preparation Set FDA UDI

Identifiers

Primary DI / UDI-DI: 00860007711213 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Tendon/ligament graft preparation station

StitchStand by Winter Innovations, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tendon/ligament graft preparation station.

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Avenue L — Ldr Spine USA · Class I
GRAFT PREP TABLE — Biomet Orthopedics, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Accessories, arthroscopic — PARCUS MEDICAL LLC · Class I
Arthrex® — Arthrex, Inc. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Winter Innovations, Inc.

Sources (1)

FDA UDI 7116a094-019b-4f56-ab21-c041c89ddd32 34 fields · synced May 30, 2026