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Ascension PIP

FDA UDI

Class Unclassified (US FDA UDI)

by Ascension Orthopedics, Inc.

Identity

Trade Name
Ascension PIP FDA UDI
Generic Name
Proximal interphalangeal joint prosthesis, modular FDA UDI
Device Name
Proximal Inter-Phalangeal Joint Replacement Device FDA UDI
Model / Reference
PIP-200-30P-WW FDA UDI
Description
Proximal Inter-Phalangeal Joint Replacement Device FDA UDI

Identifiers

Catalog Number
PIP-200-30P-WW FDA UDI
Primary DI / UDI-DI
10381780000488 FDA UDI
PMA Number
H010005 FDA UDI
FDA Product Code
OMX FDA UDI
GMDN Term
Proximal interphalangeal joint prosthesis, modular FDA UDI

Classification

Device Class
Unclassified FDA UDI
Commercial Distribution
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

No

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
Moist Heat or Steam Sterilization FDA UDI

Category: Proximal interphalangeal joint prosthesis, modular

Ascension PIP by Ascension Orthopedics, Inc. — Class Unclassified — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Proximal interphalangeal joint prosthesis, modular.

Cleared under the same submission

H010005 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Ascension Orthopedics, Inc.

Sources (1)

  • FDA UDI 9b001c65-9ffb-4378-9031-1d71d606913b 38 fields · synced May 30, 2026