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SuperCable® ISO-Elastic™ Cerclage System

FDA UDI

Class I (US FDA UDI)

by Kinamed, Inc.

Identity

Trade Name
SuperCable® ISO-Elastic™ Cerclage System FDA UDI
Generic Name
Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Device Name
Curved Mini Passer (For use with 1.5mm SuperCable Implant) FDA UDI
Model / Reference
38-800-3400 FDA UDI
Description
Curved Mini Passer (For use with 1.5mm SuperCable Implant) FDA UDI

Identifiers

Catalog Number
38-800-3400 FDA UDI
Primary DI / UDI-DI
00818720011332 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic surgical procedure kit, non-medicated, reusable 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Orthopaedic surgical procedure kit, non-medicated, reusable

SuperCable® ISO-Elastic™ Cerclage System by Kinamed, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kinamed, Inc.

Sources (1)

  • FDA UDI 2d656d23-42c3-4d53-bacb-f4e946d3d57c 34 fields · synced Jun 1, 2026