Ascension®

FDA UDI

Class I (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name: Ascension® FDA UDI
Generic Name: Bone cutter FDA UDI
Device Name: Ascension® MCP The MCP disposable pack for Linvatec/Hall includes a blade and a side burr. FDA UDI
Model / Reference: MCP-DIS-HAL FDA UDI
Description: Ascension® MCP The MCP disposable pack for Linvatec/Hall includes a blade and a side burr. FDA UDI

Identifiers

Catalog Number: MCPDISHAL FDA UDI
Primary DI / UDI-DI: 10381780246015 FDA UDI
FDA Product Code: HTZ FDA UDI
HTT FDA UDI
GMDN Term: Bone cutter FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 FDA UDI
888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

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Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Bone cutter

Ascension® by Ascension Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Ascension Orthopedics, Inc.

Sources (1)

FDA UDI 8c7b8c11-25aa-4291-b9cf-6bb406950fbd 36 fields · synced May 31, 2026