FDA UDI
In Commercial Distribution
🇺🇸 United States
Sequa® Sorb
DI: 06931132203103
·
Model: 2.5x30cm
·
Foshan United Medical Technologies Ltd.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sequa® Sorb
- Primary DI
- 06931132203103
- Version / Model
- 2.5x30cm
- Catalog Number
- SQ1A2535
- Company Name
- Foshan United Medical Technologies Ltd.
- Labeler DUNS
- 421269241
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-09-18
- Public Version
- 1
- Public Version Date
- 2023-09-26
- Public Version Status
- New
- Public Device Record Key
- 56732c26-ab96-4d13-9c63-0e9c3aa61196
Device Description
Sequa®Sorb Alginate Wound Dressing is a sterile non-woven calcium/sodium alginate dressing consisting of a high gel strength alginate. The Sequa®Sorb Alginate Wound Dressing is highly absorbent, conformable and wet integral. As wound exudate is absorbed the alginate forms a gel, which assists in maintaining a moist environment for optimal wound healing, aids autolytic debridement, and allows intact removal.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NAC | Dressing, Wound, Hydrophilic | General, Plastic Surgery | 878.4018 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46854 | Wound-nonadherent dressing, absorbent, non-antimicrobial | A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06931132203103 | GS1 |