Identity
- Trade Name
- BIOMOL FDA UDI
- Generic Name
- Body aspiration needle, single-use FDA UDI
- Device Name
- BIOMOL 20GX100MM FDA UDI
- Model / Reference
- BIOMOL FDA UDI
- Description
- BIOMOL 20GX100MM FDA UDI
Identifiers
- Catalog Number
- BM 2010 FDA UDI
- Primary DI / UDI-DI
- 08033003340707 FDA UDI
- 510(k) Number
- K002947 FDA UDI
- FDA Product Code
- FCG FDA UDI
- GMDN Term
- Body aspiration needle, single-use 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 100 Millimeter FDA UDINeedle Gauge — 20 Gauge FDA UDI
Category: Body aspiration needle, single-use
Biomol by H.s. Hospital Service Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Body aspiration needle, single-use.
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- COMPLETE-CHIBA MR — STERYLAB SRL · Class II
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Cleared under the same submission
K002947 also covers:
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
- BIOMOL — H.S. HOSPITAL SERVICE SPA
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 II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- H.s. Hospital Service Spa
Sources (1)
- FDA UDI 20695f67-ed28-45f8-9433-28b9c208f1a3 37 fields · synced May 31, 2026