Identity
- Trade Name
- Screw Dilator FDA UDI
- Generic Name
- Fascial tissue dilator, single-use FDA UDI
- Device Name
- Screw Dilator 10F x 25cm FDA UDI
- Model / Reference
- 631038025 FDA UDI
- Description
- Screw Dilator 10F x 25cm FDA UDI
Identifiers
- Catalog Number
- 631038025 FDA UDI
- Primary DI / UDI-DI
- 00886333004935 FDA UDI
- 510(k) Number
- K990808 FDA UDI
- FDA Product Code
- GCC FDA UDI
- GMDN Term
- Fascial tissue dilator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4200 FDA UDI
- Commercial Distribution
- Not 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
Yes
FDA UDI
Screw Dilator by Argon Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Argon Medical Devices, Inc.
Sources (1)
- FDA UDI c574987e-9ee2-4308-bc36-4c319a60b97d 38 fields · synced Jun 9, 2026