Identity
- Trade Name
- HMG Spinal Needle FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- Spinal Needle, 20G Non-sterile FDA UDI
- Model / Reference
- SPN20G35QNS FDA UDI
- Description
- Spinal Needle, 20G Non-sterile FDA UDI
Identifiers
- Catalog Number
- SPN20G35QNS FDA UDI
- Primary DI / UDI-DI
- 10850048235158 FDA UDI
- 510(k) Number
- K212982 FDA UDI
- FDA Product Code
- BSP FDA UDI
- GMDN Term
- Spinal needle, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 868.5150 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Category: Spinal needle, single-use
HMG Spinal Needle by Hartman Medical Group, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212982 also covers:
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 |
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Manufacturer
- Manufacturer
- Hartman Medical Group, LLC
Sources (1)
- FDA UDI d1517db3-39da-4ae3-a5c8-57c989660410 35 fields · synced Jun 8, 2026