Imbibe

FDA UDI

Class I (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: Imbibe FDA UDI
Generic Name: Body aspiration needle, single-use FDA UDI
Device Name: Fenestrated Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet FDA UDI
Model / Reference: 2090-9030 FDA UDI
Description: Fenestrated Bone Marrow Aspiration Needle with Bullet Tip, Bullet Tip Stylet, Stylet FDA UDI

Identifiers

Catalog Number: 2090-9030 FDA UDI
Primary DI / UDI-DI: 07613327123579 FDA UDI
510(k) Number: K153306 FDA UDI
FDA Product Code: LXH FDA UDI
KNW FDA UDI
GMDN Term: Body aspiration needle, single-use FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
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: Length — 15.0 Centimeter FDA UDI
Needle Gauge — 8.0 Gauge FDA UDI

Category: Body aspiration needle, single-use

Imbibe by Stryker Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Body aspiration needle, single-use.

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Echotip — COOK INCORPORATED · Class I
COMPLETE-CHIBA MR — STERYLAB SRL · Class II
Invivo — Philips DS North America LLC · Class II
BIOMOL — H.S. HOSPITAL SERVICE SPA · Class II
MReye — COOK INCORPORATED · Class II

Cleared under the same submission

K153306 also covers:

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: Stryker Corp.

Sources (1)

FDA UDI 3c7596f5-c5bd-45cc-b858-ae94135de11b 38 fields · synced May 30, 2026