← Back to catalogue

Gyrus Acmi

FDA UDI

Class II (US FDA UDI)

by Gyrus Acmi, Inc.

Identity

Trade Name
GYRUS ACMI FDA UDI
Generic Name
Polyethylene craniofacial tissue reconstructive material FDA UDI
Device Name
KARTUSH HYDROXYLAPATITE DISK 14MM FDA UDI
Model / Reference
70921786 FDA UDI
Description
KARTUSH HYDROXYLAPATITE DISK 14MM FDA UDI

Identifiers

Primary DI / UDI-DI
00821925021464 FDA UDI
510(k) Number
K863237 FDA UDI
FDA Product Code
LYC FDA UDI
GMDN Term
Polyethylene craniofacial tissue reconstructive material FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.3930 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Polyethylene craniofacial tissue reconstructive material

Gyrus Acmi by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polyethylene craniofacial tissue reconstructive material.

Cleared under the same submission

K863237 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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

Manufacturer

Manufacturer
Gyrus Acmi, Inc.

Sources (1)

  • FDA UDI 257bcc54-dc67-4ad0-ad12-a1276912a7e3 35 fields · synced May 31, 2026