Identity
- Trade Name
- AMSure® 100% Silicone Foley Catheter FDA UDI
- Generic Name
- Indwelling urethral drainage balloon catheter, non-antimicrobial FDA UDI
- Device Name
- AMSure® 100% Silicone Foley Catheter Radiopaque FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- AMSure® 100% Silicone Foley Catheter Radiopaque FDA UDI
Identifiers
- Catalog Number
- AS43016S FDA UDI
- Primary DI / UDI-DI
- 10704411002116 FDA UDI
- 510(k) Number
- K082815 FDA UDI
- FDA Product Code
- EZL FDA UDI
- GMDN Term
- Indwelling urethral drainage balloon catheter, non-antimicrobial 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
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
No
FDA UDI
Category: Indwelling urethral drainage balloon catheter, non-antimicrobial
AMSure® 100% Silicone Foley Catheter by Amsino International, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Indwelling urethral drainage balloon catheter, non-antimicrobial.
- Sunmed — SunMed · Class II
- Dover — Cardinalhealth · Class II
- Silicone Foley Catheters — Dynarex Corp. · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- RUSCH — TELEFLEX INCORPORATED · Class II
- Porges Coloplast — Coloplast A/S · Class II
- Latex Foley Catheter — Well Lead Medical Co., Ltd · Class II
Cleared under the same submission
K082815 also covers:
- AMSure® 100% Silicone Foley Catheter — AMSINO INTERNATIONAL, INC.
- AMSure® Silicone Coated Latex Foley Catheter — AMSINO INTERNATIONAL, INC.
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Foley Catheter — GERI-GENTLE CORPORATION
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, INC.
- Medline — MEDLINE INDUSTRIES, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Amsino International, Inc.
Sources (1)
- FDA UDI a88812e2-92f7-4a32-83ad-038fde8a646f 35 fields · synced Jun 6, 2026