Identity
- Trade Name
- SB Soft Hood /Straight type FDA UDI
- Generic Name
- Endoscope hood FDA UDI
- Device Name
- The Product is a transparent distal attachment applied to the tip of the endoscope. It is used in ESD procedures. This Product is used for maintaining visualization during the dissection phase of the procedure. This Product contains drainage side hole that allows egress of water and blood. This Product is disposable and in a variety of diameters that correspond to different endoscope sizes. FDA UDI
- Model / Reference
- MD-47970 FDA UDI
- Description
- The Product is a transparent distal attachment applied to the tip of the endoscope. It is used in ESD procedures. This Product is used for maintaining visualization during the dissection phase of the procedure. This Product contains drainage side hole that allows egress of water and blood. This Product is disposable and in a variety of diameters that correspond to different endoscope sizes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04545499068903 FDA UDI
- FDA Product Code
- FDS FDA UDI
- GMDN Term
- Endoscope hood 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
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 16.2 Millimeter FDA UDI
Category: Endoscope hood
SB Soft Hood /Straight type by Sb-Kawasumi Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Endoscope hood.
- SB Soft Hood /Straight type — SB-KAWASUMI LABORATORIES, INC. · Class II
- SB Soft Hood /Undercut type — SB-KAWASUMI LABORATORIES, INC. · Class II
- SB Soft Hood /Straight type — SB-KAWASUMI LABORATORIES, INC. · Class II
- SB Soft Hood /Undercut type — SB-KAWASUMI LABORATORIES, INC. · Class II
- SB Soft Hood /Undercut type — SB-KAWASUMI LABORATORIES, INC. · Class II
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
- Sb-Kawasumi Laboratories, Inc.
Sources (1)
- FDA UDI 876edabf-985a-4b15-9ae8-aec0e5afb7ca 34 fields · synced Jun 1, 2026