FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Up&Up
DI: 00017276234893
·
Model: 245070866
·
TARGET CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
3
Basic Information
- Brand Name
- Up&Up
- Primary DI
- 00017276234893
- Version / Model
- 245070866
- Company Name
- TARGET CORPORATION
- Labeler DUNS
- 006961700
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 3
- Record Status
- Published
- Publish Date
- 2020-09-27
- Public Version
- 2
- Public Version Date
- 2023-09-22
- Public Version Status
- Update
- Public Device Record Key
- 05ff1eb4-502e-4f76-bb6d-567e3bb369d9
- Distribution End Date
- 2022-12-17
Device Description
Hydrogel Burn Pads, all one size, 1.96 IN x 2.95 IN (4.9 cm x 7.4 cm)
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
- 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 |
|---|---|---|---|---|
| NAE | Dressing, Wound, Hydrogel Without Drug And/Or Biologic | General, Plastic Surgery | 878.4022 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47764 | Wound hydrogel dressing, non-antimicrobial | A wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases; it does not include an antimicrobial agent(s). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10017276234890 | GS1 | case | 72 | Not in Commercial Distribution | 2022-12-17 |
| Primary | 00017276234893 | GS1 | ||||
| Unit of Use | 60017276234895 | GS1 |
Customer Contacts
- Phone
- 18009106874
- [email protected]