Identity
- Trade Name
- Skater™ Safety Centesis Catheter FDA UDI
- Generic Name
- Abdominal paracentesis needle, single-use FDA UDI
- Device Name
- Skater™ Safety Centesis Catheter 8F x 12cm with Air Lock Valve FDA UDI
- Model / Reference
- 700508012 FDA UDI
- Description
- Skater™ Safety Centesis Catheter 8F x 12cm with Air Lock Valve FDA UDI
Identifiers
- Catalog Number
- 700508012 FDA UDI
- Primary DI / UDI-DI
- 00886333225040 FDA UDI
- FDA Product Code
- OJT FDA UDI
- GMDN Term
- Abdominal paracentesis needle, single-use 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: Abdominal paracentesis needle, single-use
Skater™ Safety Centesis Catheter by Argon Medical Devices, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 8cadecd2-81c6-4b54-bd3e-6f4ba8ff01ad 36 fields · synced Jun 9, 2026