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NeuroPro® Low Profile

FDA UDI

Class II (US FDA UDI)

by Kinamed, Inc.

Identity

Trade Name
NeuroPro® Low Profile FDA UDI
Generic Name
Cranioplasty plate, alterable FDA UDI
Device Name
Bone Plate FDA UDI
Model / Reference
16-1P1-0812 FDA UDI
Description
Bone Plate FDA UDI

Identifiers

Catalog Number
16-1P1-0812 FDA UDI
Primary DI / UDI-DI
00898142001616 FDA UDI
FDA Product Code
GWO FDA UDI
GMDN Term
Cranioplasty plate, alterable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5320 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

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

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Cranioplasty plate, alterable

NeuroPro® Low Profile by Kinamed, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cranioplasty plate, alterable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Kinamed, Inc.

Sources (1)

  • FDA UDI cc8e4403-7652-456c-8353-6d8ff6b72c81 34 fields · synced May 31, 2026