Identity
- Trade Name
- Future Generation Medical FDA UDI
- Generic Name
- Spinal needle, single-use FDA UDI
- Device Name
- FGM Spinal Needle 29G Quincke Tip FDA UDI
- Model / Reference
- AL29SQ FDA UDI
- Description
- FGM Spinal Needle 29G Quincke Tip FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10850046230148 FDA UDI
- 510(k) Number
- K171518 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Future Generation Medical by Global International L. L. C. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K171518 also covers:
- Future Generation Medical — Global International L. L. C.
- Future Generation Medical — Global International L. L. C.
- Future Generation Medical — Global International L. L. C.
- Future Generation Medical — Global International L. L. C.
- Future Generation Medical — Global International L. L. C.
- Future Generation Medical — Global International L. L. C.
- Future Generation Medical — Global International L. L. C.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC.
- Busse Hospital Disposables — ROBERT BUSSE & CO., INC.
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
- Global International L. L. C.
Sources (1)
- FDA UDI a622ad59-0720-4c03-862c-458f035c7f87 35 fields · synced May 30, 2026