Biopsybell

FDA UDI

Class I (US FDA UDI)

by Biopsybell Srl

Identity

Trade Name: BIOPSYBELL FDA UDI
Generic Name: Bone access channel kit FDA UDI
Device Name: KYPHOPLASTY WORKING CANNULA AND BEVEL TIP FDA UDI
Model / Reference: CIFOPACK WORKING CANNULA AND BEVEL TIP FDA UDI
Description: KYPHOPLASTY WORKING CANNULA AND BEVEL TIP FDA UDI

Identifiers

Catalog Number: KPA11-WB FDA UDI
Primary DI / UDI-DI: 08033860036942 FDA UDI
FDA Product Code: OCJ FDA UDI
GMDN Term: Bone access channel kit 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

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

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

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Needle Gauge — 11 Gauge FDA UDI
Length — 120 Millimeter FDA UDI

Category: Bone access channel kit

Biopsybell by Biopsybell Srl — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone access channel kit.

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Osseoflex® — Merit Medical Systems, Inc. · Class I
OsteoCool™ Bone Access Kit — MEDTRONIC SOFAMOR DANEK, INC. · Class I
Drill — Shanghai Kinetic Medical Co., Ltd. · Class II
KYPHON® One-Step™ Osteo Introducer™ System — MEDTRONIC SOFAMOR DANEK, INC. · Class I
0.035" x 5" K-Wire Standard — Trilliant Surgical LLC · 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 I	Pending data

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Manufacturer

Manufacturer: Biopsybell Srl

Sources (1)

FDA UDI 7ddb1c8a-f3b2-4b12-a6b3-3c67cbd2104c 36 fields · synced May 30, 2026