Identity
- Trade Name
- Silicone Silo Bag with Wire Ring Sizer Ring FDA UDI
- Generic Name
- Negative-pressure wound therapy open-abdomen dressing FDA UDI
- Device Name
- Silicone Silo Bag with Wire Ring Sizer Ring For Use with the SSP Silicone Silo Bag FDA UDI
- Model / Reference
- SSB-SR-03 FDA UDI
- Description
- Silicone Silo Bag with Wire Ring Sizer Ring For Use with the SSP Silicone Silo Bag FDA UDI
Identifiers
- Catalog Number
- SSB-SR-03 FDA UDI
- Primary DI / UDI-DI
- M746SSBSR030 FDA UDI
- 510(k) Number
- K973082 FDA UDI
- FDA Product Code
- FTL FDA UDI
- GMDN Term
- Negative-pressure wound therapy open-abdomen dressing FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3300 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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Width — 3.0 Centimeter FDA UDI
Category: Negative-pressure wound therapy open-abdomen dressing
Silicone Silo Bag with Wire Ring Sizer Ring by Specialty Surgical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Negative-pressure wound therapy open-abdomen dressing.
- ABTHERA™ — KCI USA, INC. · Class II
- Solventum US LLC — KCI USA, INC. · Class II
- Wittmann Patch — PRESERVATION SOLUTIONS, INC. · Class II
- Solventum US LLC — KCI USA, INC. · Class II
- ABTHERA ADVANCE™ — KCI USA, INC. · Class II
- ABTHERA™ SENSAT.R.A.C.™ — KCI USA, INC. · Class II
- V.A.C.® — KCI USA, INC. · Class II
- Solventum US LLC — KCI USA, INC. · Class II
Cleared under the same submission
K973082 also covers:
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, INC.
- Silicone Silo Bag — SPECIALTY SURGICAL PRODUCTS, 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
- Specialty Surgical Products, Inc.
Sources (1)
- FDA UDI 2bd88e84-e6fb-4ec6-9be8-4aacdf5e0eaf 37 fields · synced May 30, 2026