iVAS

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: iVAS FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: Bone Biopsy Kit FDA UDI
Model / Reference: 0306116000 FDA UDI
Description: Bone Biopsy Kit FDA UDI

Identifiers

Catalog Number: 0306-116-000 FDA UDI
Primary DI / UDI-DI: 07613252594208 FDA UDI
FDA Product Code: KNW FDA UDI
GMDN Term: Body aspiration needle, single-use FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 876.1075 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 11.0 Gauge FDA UDI

Category: Body aspiration needle, single-use

iVAS by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Invivo — Philips DS North America LLC · Class II
BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
MReye — COOK INCORPORATED · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Stryker Corp.

Sources (1)

FDA UDI 9e382b23-17f0-410b-bf84-c4f9e6cd1626 36 fields · synced Jun 8, 2026