FDA UDI
In Commercial Distribution
🇺🇸 United States
CUTICERIN 7.5X7.5CM CTN 10
DI: 05000223450182
·
Model: 66045562
·
SMITH & NEPHEW MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- CUTICERIN 7.5X7.5CM CTN 10
- Primary DI
- 05000223450182
- Version / Model
- 66045562
- Catalog Number
- 66045562
- Company Name
- SMITH & NEPHEW MEDICAL LIMITED
- Labeler DUNS
- 216344051
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-11-24
- Public Version
- 2
- Public Version Date
- 2023-09-07
- Public Version Status
- Update
- Public Device Record Key
- 728a0941-56dc-4671-9189-77982fe64c64
Device Description
Impregnated Gauze Dressing
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| FRO | Dressing, Wound, Drug | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46855 | Wound-nonadherent dressing, permeable, non-antimicrobial | A wound covering typically in the form of a porous material (e.g., a fine mesh) impregnated/coated with a substance (e.g., petrolatum, silicone) or made of a material that prevents adherence to the wound bed, thereby decreasing the potential for trauma to the wound and surrounding skin upon removal; it does not contain an antimicrobial agent. Its pores permit the drainage of exudates from, and application of medication to, the wound. It may be used with other wound-care products for chronic and postoperative wounds, burns, skin graft fixation/cultured-cell carrier, cuts, or abrasions; it is neither a dedicated burn dressing nor gauze. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 05000223450199 | GS1 | Carton | 10 | In Commercial Distribution | |
| Primary | 05000223450182 | GS1 | ||||
| Package | 05000223450205 | GS1 | Case | 12 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K842967 | 000 |