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INRO Surgical Nail

FDA UDI

Class I (US FDA UDI)

by Inro Medical Designs, Inc.

Identity

Trade Name
INRO Surgical Nail FDA UDI
Generic Name
Hand/finger splint, single-use FDA UDI
Device Name
Nail splint for the reconstructive surgery of the nail bed. FDA UDI
Model / Reference
00-4R FDA UDI
Description
Nail splint for the reconstructive surgery of the nail bed. FDA UDI

Identifiers

Catalog Number
4R FDA UDI
Primary DI / UDI-DI
00861887000213 FDA UDI
FDA Product Code
FYH FDA UDI
GMDN Term
Hand/finger splint, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
878.3910 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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 14 Millimeter FDA UDI

Category: Hand/finger splint, single-use

INRO Surgical Nail by Inro Medical Designs, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hand/finger splint, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Inro Medical Designs, Inc.

Sources (1)

  • FDA UDI 641f41c8-2716-415c-b629-5f9ae90109c7 36 fields · synced Jun 8, 2026