Identity
- Trade Name
- GYRUS ACMI FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- O-RING, ETHYLENE 0.426 ID, 0.040 WIDTH FDA UDI
- Model / Reference
- 70921443 FDA UDI
- Description
- O-RING, ETHYLENE 0.426 ID, 0.040 WIDTH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00821925022973 FDA UDI
- 510(k) Number
- K932988 FDA UDI
- FDA Product Code
- EOB FDA UDI
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4760 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: Endoscope working-channel valve, single-use
Gyrus Acmi by Gyrus Acmi, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope working-channel valve, single-use.
- Dragonfly Pancreaticobiliary Scope and Instrument Channel Caps — CenterPoint Systems LLC · Class II
- Disposable Biopsy Valve — Micro-tech Usa · Class II
- Edge — Covidien LP · Class II
- CONMED CLEARGUARD — Conmed Corporation · Class II
- Edge — Covidien LP · Class II
- Edge — Covidien LP · Class II
- BioShield — US Endoscopy · Class II
- Edge — Covidien LP · Class II
Cleared under the same submission
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
- Gyrus Acmi, Inc.
Sources (1)
- FDA UDI bf3b169a-33b3-43c5-a7e2-835d3b5dce9f 34 fields · synced May 30, 2026