FDA UDI
In Commercial Distribution
🇺🇸 United States
CONFORMANT 2 WND VL4X4IN CS48
DI: 00040565119304
·
Model: 5955044
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CONFORMANT 2 WND VL4X4IN CS48
- Primary DI
- 00040565119304
- Version / Model
- 5955044
- Catalog Number
- 5955044
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-16
- Public Version
- 2
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 46760c57-6546-440a-aa98-37230ef1b80f
Device Description
Polyethylene wound contact layer
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
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 46735 | Fluid-permeable film dressing | A sterile, transparent covering that is permeable to fluids intended to be applied to wounded or diseased tissue to provide protection (e.g., from dirt, microbes) and/or promote healing. It is a thin, clear, hydrophilic membrane made of synthetic polymer (e.g., polyurethane based) without an adhesive. It is applied directly to tissue to protect and/or help heal (e.g., as a synthetic skin) burns, skin-graft donor sites, ulcers, laser resurfacing sites, or other partial-thickness wounds. Its permeability allows the passage of wound exudates without removal; the device may be perforated (e.g., meshed) for increased permeability for highly-exudative wounds. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 30040565119305 | GS1 | Case | 48 | In Commercial Distribution | |
| Primary | 00040565119304 | GS1 |