Identity
- Trade Name
- Blue Silicone FDA UDI
- Generic Name
- Endoscope sheath, reusable FDA UDI
- Device Name
- Blue Silicone Seal for 6 to 12 FR (2 to 4 mm) Accessories (12/PK) FDA UDI
- Model / Reference
- CS-B612 FDA UDI
- Description
- Blue Silicone Seal for 6 to 12 FR (2 to 4 mm) Accessories (12/PK) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925038318 FDA UDI
- 510(k) Number
- K890328 FDA UDI
- FDA Product Code
- HIH FDA UDI
- GMDN Term
- Endoscope sheath, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 884.1690 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Endoscope sheath, reusable
Blue Silicone by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K890328 also covers:
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- Elite 2 System — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI — Gyrus Acmi, Inc.
- GYRUS ACMI, INC — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, Inc.
- Gyrus ACMI — Gyrus Acmi, 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 |
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Manufacturer
- Manufacturer
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI 3026f79d-929a-4fef-ba8f-6e32a3d52d6a 34 fields · synced May 30, 2026