FDA UDI
In Commercial Distribution
🇺🇸 United States
Equate
DI: 00194346192038
·
Model: 194346192038
·
WAL-MART STORES, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
30
Basic Information
- Brand Name
- Equate
- Primary DI
- 00194346192038
- Version / Model
- 194346192038
- Company Name
- WAL-MART STORES, INC.
- Labeler DUNS
- 051957769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 30
- Record Status
- Published
- Publish Date
- 2024-02-15
- Public Version
- 1
- Public Version Date
- 2024-02-23
- Public Version Status
- New
- Public Device Record Key
- acd382b0-a315-4c26-be0c-8f71c686ea2f
Device Description
Wound Closures, all one size, 1/4 IN x 4 IN
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FPX | Strip, Adhesive, Closure, Skin | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 32207 | Skin-closure adhesive strip | A small, narrow flexible band (of fabric, plastic, paper, or other material) coated on one side with a pressure-sensitive adhesive, used to approximate the edges of superficial wounds. The device may be hypoallergenic and/or waterproof. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20194346192032 | GS1 | case | 36 | In Commercial Distribution | |
| Primary | 00194346192038 | GS1 | ||||
| Unit of Use | 60194346192030 | GS1 |
Customer Contacts
- Phone
- 18558234545
- [email protected]