← Back to catalogue

Distraction, Internal

FDA UDI

Class I (US FDA UDI)

by KLS-Martin L.P.

Identity

Trade Name
DISTRACTION, INTERNAL FDA UDI
Generic Name
Implantable craniofacial bone distractor FDA UDI
Model / Reference
990-4270-01 FDA UDI

Identifiers

Primary DI / UDI-DI
00888118093035 FDA UDI
FDA Product Code
FZX FDA UDI
GMDN Term
Implantable craniofacial bone distractor FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.4800 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Distraction, Internal by KLS-Martin L.P. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
KLS-Martin L.P.

Sources (1)

  • FDA UDI 0ce26feb-cee8-4e63-acee-979ee747ea54 34 fields · synced May 31, 2026