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Clearcut

FDA UDI

Class II (US FDA UDI)

by Teknimed

Identity

Trade Name
CLEARCUT FDA UDI
Generic Name
Polymer orthopaedic cement restrictor, bioabsorbable FDA UDI
Model / Reference
Diameter 08 FDA UDI

Identifiers

Catalog Number
415-00-080 FDA UDI
Primary DI / UDI-DI
03760177046542 FDA UDI
FDA Product Code
LZN FDA UDI
GMDN Term
Polymer orthopaedic cement restrictor, bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.3300 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 8 Millimeter FDA UDI

Category: Polymer orthopaedic cement restrictor, bioabsorbable

Clearcut by Teknimed — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Polymer orthopaedic cement restrictor, bioabsorbable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Teknimed

Sources (1)

  • FDA UDI ebedbb6a-df79-4bca-b602-7848a636a823 35 fields · synced May 30, 2026