Identity
- Trade Name
- Koala™ FDA UDI
- Generic Name
- Medical device cleaning sponge/set FDA UDI
- Device Name
- Cleaning Sponge FDA UDI
- Model / Reference
- SSB-210 FDA UDI
- Description
- Cleaning Sponge FDA UDI
Identifiers
- Catalog Number
- SSB-210 FDA UDI
- Primary DI / UDI-DI
- 08714729989745 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Medical device cleaning sponge/set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Medical device cleaning sponge/set
Koala™ by Boston Scientific — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Medical device cleaning sponge/set.
- ECO EZ CLEANSE — Meditech Endoscopy, Ltd. · Class I
- Ultracell® — Beaver-Visitec International, Inc. · Class II
- First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad — CYGNUS MEDICAL L.L.C. · Class I
- SUMMIT MEDICAL — Summit Medical, LLC · Class II
- Halyard — Avanos Medical, Inc. · Class II
- WALCOTT RX PRODUCTS — Summit Medical, LLC · Class II
- First Step Bedside Kit - Stand-Up Pouch, Gemini Cleaning Pad — CYGNUS MEDICAL L.L.C. · Class I
- Cleaning Sponge — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · 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
- Boston Scientific
Sources (1)
- FDA UDI 93331a15-d58a-4f39-a89f-a3b78537e797 34 fields · synced May 31, 2026