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Ace

FDA UDI

Class I (US FDA UDI)

by Ace Surgical Supply Co., Inc.

Identity

Trade Name
ACE FDA UDI
Generic Name
Suturing needle holder, reusable FDA UDI
Device Name
NEEDLEHOLDER WEBSTER SERRATED TC 4-3/4" 12CM FDA UDI
Model / Reference
3005103 FDA UDI
Description
NEEDLEHOLDER WEBSTER SERRATED TC 4-3/4" 12CM FDA UDI

Identifiers

Catalog Number
3005103 FDA UDI
Primary DI / UDI-DI
00614950023851 FDA UDI
FDA Product Code
HXK FDA UDI
GMDN Term
Suturing needle holder, 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

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

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

Dimensions & Sizes

Size
Length — 12 Centimeter FDA UDI

Category: Suturing needle holder, reusable

Ace by Ace Surgical Supply Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Suturing needle holder, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Sources (1)

  • FDA UDI 04a972ad-f0c0-4a12-bc2e-98cbda5e44e7 37 fields · synced May 30, 2026