FDA UDI
In Commercial Distribution
🇺🇸 United States
Miraculous
DI: 00017276239126
·
Model: 017276239126
·
Aso LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
20
Basic Information
- Brand Name
- Miraculous
- Primary DI
- 00017276239126
- Version / Model
- 017276239126
- Company Name
- Aso LLC
- Labeler DUNS
- 152793493
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2022-11-09
- Public Version
- 1
- Public Version Date
- 2022-11-17
- Public Version Status
- New
- Public Device Record Key
- e7db51bc-c006-4d9d-9779-a31dd895476a
Device Description
Antibacterial Bandages, assorted shapes & Sizes, 3/4" strips, 3/4 " x 3 " (19 mm x 76 mm), 5/8" strips, 5/8" x 2 1/4" (15 mm x 57 mm), Glitter Hearts, 1.64 IN x 1.39 IN (41 mm x 35 mm)
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 |
|---|---|---|---|---|
| KGX | Tape And Bandage, Adhesive | General Hospital | 880.5240 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47378 | Skin-cover adhesive strip, antimicrobial | A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10017276239123 | GS1 | case | 72 | In Commercial Distribution | |
| Primary | 00017276239126 | GS1 | ||||
| Unit of Use | 60017276239128 | GS1 |
Customer Contacts
- Phone
- 18558234545
- [email protected]