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Distraction Screw Caspar type

FDA UDI

Class I (US FDA UDI)

by Acra-Cut Inc

Identity

Trade Name
Distraction Screw Caspar type FDA UDI
Generic Name
Intraoperative orthopaedic bone pin/screw, single-use FDA UDI
Device Name
Distraction Screw Caspar type FDA UDI
Model / Reference
800-500 FDA UDI
Description
Distraction Screw Caspar type FDA UDI

Identifiers

Catalog Number
800-500 FDA UDI
Primary DI / UDI-DI
00810607000248 FDA UDI
FDA Product Code
KDC FDA UDI
GMDN Term
Intraoperative orthopaedic bone pin/screw, single-use 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

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

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: Intraoperative orthopaedic bone pin/screw, single-use

Distraction Screw Caspar type by Acra-Cut Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative orthopaedic bone pin/screw, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Acra-Cut Inc

Sources (1)

  • FDA UDI 79530354-a3ee-4d6a-9ecd-e8a9a480b6b0 35 fields · synced May 29, 2026