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Power Dental U.S.A., Inc.

FDA UDI

Class I (US FDA UDI)

by Power Dental USA, Inc.

Identity

Trade Name
Power Dental U.S.A., Inc. FDA UDI
Generic Name
Suturing needle holder, reusable FDA UDI
Device Name
NEEDLE HOLDER T/C CASTROVIEJO STRAIGHT 16cm T/C*Please use 0.8 mm or less needle size*Please place needle near the top of the beak. NEVER place needle near the bottom*Please make sure that no other instruments are allowed to touch the locking mechanism... FDA UDI
Model / Reference
N5513 FDA UDI
Description
NEEDLE HOLDER T/C CASTROVIEJO STRAIGHT 16cm T/C*Please use 0.8 mm or less needle size*Please place needle near the top of the beak. NEVER place needle near the bottom*Please make sure that no other instruments are allowed to touch the locking mechanism... FDA UDI

Identifiers

Catalog Number
N5513 FDA UDI
Primary DI / UDI-DI
D943N5513 FDA UDI
FDA Product Code
FHQ FDA UDI
GMDN Term
Suturing needle holder, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
876.4730 FDA UDI
Commercial Distribution
Not 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

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

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 13d8928f-053c-4b1f-8077-bd4de316c5e2 36 fields · synced Jun 1, 2026