Identity
- Trade Name
- SoftFil® Precision FDA UDI
- Generic Name
- Tissue injection cannula FDA UDI
- Device Name
- SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pre-hole needle in its protective cap, - 1 stainless steel, graduated blunt-tip needle (micro-cannula) 18G x 70 mm in its protective cap. FDA UDI
- Model / Reference
- CP1870U FDA UDI
- Description
- SoftFil® Precision are sterile and single use injection kits containing: - 1 stainless steel pre-hole needle in its protective cap, - 1 stainless steel, graduated blunt-tip needle (micro-cannula) 18G x 70 mm in its protective cap. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10669808002509 FDA UDI
- FDA Product Code
- GEA FDA UDI
- GMDN Term
- Tissue injection cannula 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
Yes
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
Yes
FDA UDI
Category: Tissue injection cannula
SoftFil® Precision by Prollenium Medical — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Tissue injection cannula.
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- STERiGLIDE TM — TSK LABORATORY, JAPAN · Class I
- DISPOSABLE MICRO CANNULA FOR FILLER INJECTION KIT — AESTHETIC GROUP · Class I
- STERiGLIDE TM — TSK LABORATORY, JAPAN · Class I
- DISPOSABLE FAT INJECTION CANNULA — AESTHETIC GROUP · 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
- Prollenium Medical
Sources (1)
- FDA UDI f0e44bf1-555d-4e6b-8d46-576b4303d6f1 33 fields · synced Jun 6, 2026