Identity
- Trade Name
- BoneHog FDA UDI
- Generic Name
- Blood cell harvesting system FDA UDI
- Device Name
- BoneHog 8mm Collection Chamber FDA UDI
- Model / Reference
- LM-08 FDA UDI
- Description
- BoneHog 8mm Collection Chamber FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810633020708 FDA UDI
- FDA Product Code
- GEY FDA UDI
- GMDN Term
- Blood cell harvesting system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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
Yes
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
- Length — 8 Millimeter FDA UDI
Category: Blood cell harvesting system
BoneHog by Biomedical Enterprises, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Blood cell harvesting system.
- BoneHog — Biomedical Enterprises, Inc. · Class I
- BoneHog — Biomedical Enterprises, Inc. · Class I
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
- Biomedical Enterprises, Inc.
Sources (1)
- FDA UDI 00f0cb42-373f-4082-98ae-36f13d27ec33 36 fields · synced May 31, 2026