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Power Dental USA

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name
Power Dental USA FDA UDI
Generic Name
Dressing/utility forceps, scissors-like, reusable FDA UDI
Device Name
GBR FIX SCREW 2.0 X 8 mm FDA UDI
Model / Reference
1981N-14 FDA UDI
Description
GBR FIX SCREW 2.0 X 8 mm FDA UDI

Identifiers

Catalog Number
1981N-14 FDA UDI
Primary DI / UDI-DI
D9431981N14 FDA UDI
FDA Product Code
HWD FDA UDI
GMDN Term
Dressing/utility forceps, scissors-like, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI

Lot / Batch Number

No

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: Dressing/utility forceps, scissors-like, reusableIntraoperative orthopaedic bone pin/screw, single-use

Power Dental USA by Power Dental USA, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intraoperative orthopaedic bone pin/screw, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Power Dental USA, Inc.

Sources (1)

  • FDA UDI 7941ce5c-0b75-4373-b0c6-72718e92985e 35 fields · synced May 30, 2026