FDA UDI
In Commercial Distribution
🇺🇸 United States
microMend
DI: 00850018777261
·
Model: MSXWD004
·
Kitotech Medical Inc
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- microMend
- Primary DI
- 00850018777261
- Version / Model
- MSXWD004
- Catalog Number
- MSXWD004
- Company Name
- Kitotech Medical Inc
- Labeler DUNS
- 007908602
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-08
- Public Version
- 1
- Public Version Date
- 2022-12-16
- Public Version Status
- New
- Public Device Record Key
- 8b3e4828-b370-48d8-a129-2116fe4422b0
Device Description
Emergency Laceration Closures (Qty. 5), VARIETY: 1 Pack of 2 SMALL 1/4 IN x 1 IN (7 mm x 28 mm); 1 Pack of 2 MEDIUM 1/2 IN x 1 IN (12 mm x 28 mm); 1 ONE 1 IN x 1 IN (25 mm x 28mm)
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
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| GDT | Staple, Removable (Skin) | General, Plastic Surgery | 878.4760 | 1 |
| KGX | Tape And Bandage, Adhesive | 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 |
|---|---|---|---|---|---|---|
| Primary | 00850018777261 | GS1 |
Customer Contacts
- Phone
- (877) 420-1502
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 16 – 26 Degrees Celsius