Sterna-Form Retractor

FDA UDI

Class I (US FDA UDI)

by Koros USA, Inc.

Identity

Trade Name: Sterna-Form Retractor FDA UDI
Generic Name: Self-retaining surgical retractor, reusable FDA UDI
Device Name: Sterna-Form Spreader Pediatric Size 2, 2-3/4" Arm Length, 2-1/2" Spread FDA UDI
Model / Reference: 8650-75 FDA UDI
Description: Sterna-Form Spreader Pediatric Size 2, 2-3/4" Arm Length, 2-1/2" Spread FDA UDI

Identifiers

Catalog Number: 8650-75 FDA UDI
Primary DI / UDI-DI: 10840199536235 FDA UDI
FDA Product Code: GAD FDA UDI
GMDN Term: Self-retaining surgical retractor, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Self-retaining surgical retractor, reusable

Sterna-Form Retractor by Koros USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Self-retaining surgical retractor, reusable.

Avalign — AVALIGN TECHNOLOGIES, Inc. · Class I
Avalign — AVALIGN TECHNOLOGIES, Inc. · Class II
Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Surgical Direct — SURGICAL DIRECT, INC. · Class I
Symmetry Cloward — SYMMETRY SURGICAL INC. · Class II
Life Instruments — Life Instrument Corporation · Class I
Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
SELF RETAINING CORONOID RETRACTOR CHAIN WITH RINGS — W.H. Holden, 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

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

Manufacturer

Manufacturer: Koros USA, Inc.

Sources (1)

FDA UDI 21347768-b8e1-4828-a763-2a33ad93c336 37 fields · synced May 31, 2026