MemoFix Super Elastic Nitinol Staple System

FDA UDI

Class II (US FDA UDI)

by Smith & Nephew, Inc.

Identity

Trade Name: MemoFix Super Elastic Nitinol Staple System FDA UDI
Generic Name: Orthopaedic bone staple, non-adjustable FDA UDI
Device Name: MEMOFIX NITINOL STAPLE 8MM X 8MM X 8MM FDA UDI
Model / Reference: MS080808 FDA UDI
Description: MEMOFIX NITINOL STAPLE 8MM X 8MM X 8MM FDA UDI

Identifiers

Catalog Number: MS080808 FDA UDI
Primary DI / UDI-DI: 00885556827543 FDA UDI
FDA Product Code: JDR FDA UDI
GMDN Term: Orthopaedic bone staple, non-adjustable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone staple, non-adjustable

MemoFix Super Elastic Nitinol Staple System by Smith & Nephew, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone staple, non-adjustable.

MotoCLIP/HiMAX Step Staple — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Step Boss — Biomedical Enterprises, Inc. · Class II
Speed — Biomedical Enterprises, Inc. · Class II
Elite — Synthes · Class II
MotoBAND™ CP DynaForce® MTP — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Speed Arc — Synthes · Class II
JAWS Nitinol Staple System — Paragon 28 · Class II

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 II	Pending data

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

Manufacturer

Manufacturer: Smith & Nephew, Inc.

Sources (1)

FDA UDI 685a5594-8905-4d4d-89e4-54d15c1d1922 36 fields · synced Jun 8, 2026