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MedaSonics

FDA UDI

Class II (US FDA UDI)

by CooperSurgical, Inc.

Identity

Trade Name
MedaSonics FDA UDI
Generic Name
Proximal interphalangeal joint prosthesis, one-piece FDA UDI
Device Name
Versatone P83 Probe; 8MHz; 2.5cm FDA UDI
Model / Reference
101-0014-010 FDA UDI
Description
Versatone P83 Probe; 8MHz; 2.5cm FDA UDI

Identifiers

Primary DI / UDI-DI
00888937002546 FDA UDI
510(k) Number
K961116 FDA UDI
FDA Product Code
IYO FDA UDI
GMDN Term
Proximal interphalangeal joint prosthesis, one-piece FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Proximal interphalangeal joint prosthesis, one-piece

MedaSonics by CooperSurgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Proximal interphalangeal joint prosthesis, one-piece.

Cleared under the same submission

K961116 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CooperSurgical, Inc.

Sources (1)

  • FDA UDI e0d27f75-07ad-49bf-91ea-0847acac57f4 34 fields · synced Jun 9, 2026