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Biopsybell Srl

FDA UDI

Class II (US FDA UDI)

by Biopsybell Srl

Identity

Trade Name
BIOPSYBELL SRL FDA UDI
Generic Name
Bone marrow explant needle FDA UDI
Device Name
NEEDLE FOR BONE MARROW EXPLANT FDA UDI
Model / Reference
OBSTERN EXPLANT FDA UDI
Description
NEEDLE FOR BONE MARROW EXPLANT FDA UDI

Identifiers

Catalog Number
BTE1307 FDA UDI
Primary DI / UDI-DI
08033860042158 FDA UDI
510(k) Number
K130616 FDA UDI
FDA Product Code
FCG FDA UDI
KNW FDA UDI
GMDN Term
Bone marrow explant needle 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

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI

Dimensions & Sizes

Size
Needle Gauge — 13 Gauge FDA UDI
Length — 70 Millimeter FDA UDI

Category: Bone marrow explant needle

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

Similar devices

Also classified as Bone marrow explant needle.

Cleared under the same submission

K130616 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Biopsybell Srl

Sources (1)

  • FDA UDI 0548c8b3-1b26-4a9f-bd2c-4ef0d2180251 37 fields · synced May 31, 2026