Identity
- Trade Name
- EndoSheath Technology FDA UDI
- Generic Name
- Optical medical device procedural cover FDA UDI
- Device Name
- EndoSheath Technology for BRS-4000 Fiber Bronchoscope FDA UDI
- Model / Reference
- BF-2.8 FDA UDI
- Description
- EndoSheath Technology for BRS-4000 Fiber Bronchoscope FDA UDI
Identifiers
- Catalog Number
- 04-4103 FDA UDI
- Primary DI / UDI-DI
- 00874485003043 FDA UDI
- 510(k) Number
- K091768 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Optical medical device procedural cover FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 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
No
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: Optical medical device procedural cover
EndoSheath Technology by Cogentix Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Optical medical device procedural cover.
- SLIDE-ON® — MEDTRONIC XOMED, INC. · Class II
- SLIDE-ON® ENDOSHEATH® — MEDTRONIC XOMED, INC. · Class II
- SLIDE-ON® — MEDTRONIC XOMED, INC. · Class II
- ENDO-SCRUB® — MEDTRONIC XOMED, INC. · Class II
- SLIDE-ON® — MEDTRONIC XOMED, INC. · Class II
- VELscope — Led Dental, Inc. · Class II
- SLIDE-ON® — MEDTRONIC XOMED, INC. · Class II
- ENDO-SCRUB® — MEDTRONIC XOMED, INC. · Class II
Cleared under the same submission
K091768 also covers:
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, INC.
- EndoSheath Technology — COGENTIX MEDICAL, 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
- Cogentix Medical, Inc.
Sources (1)
- FDA UDI c5c1a745-700d-492e-baf0-975e1926a4cb 36 fields · synced Jun 8, 2026