Identity
- Trade Name
- BioShield FDA UDI
- Generic Name
- Endoscope working-channel valve, single-use FDA UDI
- Device Name
- The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channel of flexible gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation. FDA UDI
- Model / Reference
- 00711903 FDA UDI
- Description
- The BioShield EUS biopsy valve-linear is used to cover the opening to the biopsy, suction channel of flexible gastrointestinal endoscopes. It provides access for endoscopic device passage and exchange, helps maintain insufflation, minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure and provides access for irrigation. FDA UDI
Identifiers
- Catalog Number
- 00711903 FDA UDI
- Primary DI / UDI-DI
- 00724995199258 FDA UDI
- 510(k) Number
- K202583 FDA UDI
- FDA Product Code
- ODD FDA UDI
- GMDN Term
- Endoscope working-channel valve, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
Yes
FDA UDI
Category: Endoscope working-channel valve, single-use
BioShield by US Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope working-channel valve, single-use.
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- CONMED CLEARGUARD — Conmed Corporation · Class II
- Edge — Covidien LP · Class II
- Edge — Covidien LP · Class II
- Edge — Covidien LP · Class II
- SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · Class II
Cleared under the same submission
K202583 also covers:
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
- US Endoscopy
Sources (1)
- FDA UDI cddcef30-e08f-4f87-b0c2-ed0d3bb58aed 37 fields · synced May 30, 2026