Biover

FDA UDI

Class I (US FDA UDI)

by Biover AG

Identity

Trade Name: Biover FDA UDI
Generic Name: Suturing needle holder, reusable FDA UDI
Device Name: Titanium micro needle holder, 150mm length, 0.4mm tip, curved, 8mm grip FDA UDI
Model / Reference: MI8012 FDA UDI
Description: Titanium micro needle holder, 150mm length, 0.4mm tip, curved, 8mm grip FDA UDI

Identifiers

Catalog Number: MI8012 FDA UDI
Primary DI / UDI-DI: 07640174510375 FDA UDI
FDA Product Code: DWS FDA UDI
GMDN Term: Suturing needle holder, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 870.4500 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

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Outer Diameter — 0.4 Millimeter FDA UDI
Length — 150 Millimeter FDA UDI

Category: Suturing needle holder, reusable

Biover by Biover AG — 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: Biover AG

Sources (1)

FDA UDI 474c7162-e401-4979-acf3-9d88bd1eff57 36 fields · synced May 31, 2026