Identity
- Trade Name
- O'Neil Intermittent Urinary Catheter FDA UDI
- Generic Name
- Intermittent urethral catheterization kit FDA UDI
- Model / Reference
- 10 Gauge FDA UDI
Identifiers
- Catalog Number
- ONSM10 FDA UDI
- Primary DI / UDI-DI
- 09350902001164 FDA UDI
- 510(k) Number
- K993651 FDA UDI
- FDA Product Code
- GBM FDA UDI
- GMDN Term
- Intermittent urethral catheterization kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5130 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Intermittent urethral catheterization kit
O'Neil Intermittent Urinary Catheter by Go Medical Industries Pty. Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intermittent urethral catheterization kit.
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- MEDLINE — MEDLINE INDUSTRIES, INC. · Class II
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- TruCath — H R Pharmaceuticals, Inc. · Class II
- TruCath — H R Pharmaceuticals, Inc. · Class II
Cleared under the same submission
K993651 also covers:
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD.
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD.
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD.
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD.
- O'Neil Intermittent Urinary Catheter — GO MEDICAL INDUSTRIES PTY. LTD.
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
- Go Medical Industries Pty. Ltd.
Sources (1)
- FDA UDI 447e9b9f-1ea7-441a-94c5-6a91ebb90a1f 34 fields · synced Jun 6, 2026