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Biopsybell

FDA UDI

Class II (US FDA UDI)

by Biopsybell Srl

Identity

Trade Name
BIOPSYBELL FDA UDI
Generic Name
Kyphoplasty balloon catheter FDA UDI
Device Name
KYPHOPLASTY BALLOON CATHETER FDA UDI
Model / Reference
RENOVA SPINE BALLOON CATHETER FDA UDI
Description
KYPHOPLASTY BALLOON CATHETER FDA UDI

Identifiers

Catalog Number
RESB1110US FDA UDI
Primary DI / UDI-DI
08033860026288 FDA UDI
FDA Product Code
HRX FDA UDI
NDN FDA UDI
GMDN Term
Kyphoplasty balloon catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.1100 FDA UDI
888.3027 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 11 Gauge FDA UDI

Category: Kyphoplasty balloon catheter

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

Similar devices

Also classified as Kyphoplasty balloon catheter.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biopsybell Srl

Sources (1)

  • FDA UDI b40a5035-0429-4d94-ac9c-fc1983096a70 36 fields · synced May 30, 2026