← Back to catalogue

PF Apositioning Instrument

FDA UDI

Class I (US FDA UDI)

by I.T.S. GmbH

Identity

Trade Name
PF Apositioning Instrument FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
PF Apositioning Instrument FDA UDI
Model / Reference
1F0I165A FDA UDI
Description
PF Apositioning Instrument FDA UDI

Identifiers

Catalog Number
1F0I165A FDA UDI
Primary DI / UDI-DI
09120116974741 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

PF Apositioning Instrument by I.T.S. GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

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
I.T.S. GmbH

Sources (1)

  • FDA UDI 2bae0641-80d3-4c8c-b04b-dec87116fab0 35 fields · synced Jun 8, 2026