Identity
- Trade Name
- PenBone FDA UDI
- Generic Name
- Bone marrow biopsy needle, single-use FDA UDI
- Device Name
- DISPOSABLE BONE BIOPSY NEEDLE FOR ILIAC CREST MARROW ASPIRATION, LIGHT VERSION 16G X 10/75 mm FDA UDI
- Model / Reference
- PI1610/75 FDA UDI
- Description
- DISPOSABLE BONE BIOPSY NEEDLE FOR ILIAC CREST MARROW ASPIRATION, LIGHT VERSION 16G X 10/75 mm FDA UDI
Identifiers
- Catalog Number
- PI1610/75 FDA UDI
- Primary DI / UDI-DI
- 08056138585782 FDA UDI
- FDA Product Code
- DWO FDA UDI
- GMDN Term
- Bone marrow biopsy needle, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Needle Gauge — 16 Gauge FDA UDI
Category: Bone marrow biopsy needle, single-use
PenBone by M.d.l. S.r.l. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone marrow biopsy needle, single-use.
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class II
- Bone Marrow Tray — Argon Medical Devices, Inc. · Class I
- MEDBONE — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy — Argon Medical Devices, Inc. · Class I
- Monoject — Cardinalhealth · Class II
- MEDLOCK — Medax Unipersonale Srl · Class II
- Bone Marrow Biopsy Needle, RBN-116 — RANFAC CORP. · Class II
- Faset — Dio Medical Co., Ltd. · U
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- M.d.l. S.r.l.
Sources (2)
- FDA UDI 08710fd1-734b-43e3-8bb7-6b36c363e3bd 35 fields · synced Jun 20, 2026
- EUDAMED 1 fields · synced Jun 1, 2026