Wiggins Medical

FDA UDI

Class I (US FDA UDI)

by Ebner Medical Llc

Identity

Trade Name: Wiggins Medical FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Bay Needle Holder 360° rotable, shaft Ø2.7mm, Z-handle 2mm tip, TC plates without locking mechanism 1: 12cm working length - standard FDA UDI
Model / Reference: 90-401-WM FDA UDI
Description: Bay Needle Holder 360° rotable, shaft Ø2.7mm, Z-handle 2mm tip, TC plates without locking mechanism 1: 12cm working length - standard FDA UDI

Identifiers

Catalog Number: 90-401-WM FDA UDI
Primary DI / UDI-DI: 00840217909044 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 12.0 Centimeter FDA UDI
Width — 2.0 Millimeter FDA UDI

Category: Suturing needle holder, reusable

Wiggins Medical by Ebner Medical Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ebner Medical Llc

Sources (1)

FDA UDI 65830503-da4a-4dd6-98af-e9df686273a2 36 fields · synced Jun 1, 2026