FDA UDI
In Commercial Distribution
🇺🇸 United States
Goo Gone Bandage & Adhesive Remover
DI: 00070048021657
·
Model: PKT
·
MICRO-SCIENTIFIC, LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Goo Gone Bandage & Adhesive Remover
- Primary DI
- 00070048021657
- Version / Model
- PKT
- Company Name
- MICRO-SCIENTIFIC, LLC
- Labeler DUNS
- 080214481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-23
- Public Version
- 1
- Public Version Date
- 2022-08-31
- Public Version Status
- New
- Public Device Record Key
- ea6469d4-7fe4-4bcf-9e55-ab1dde27e16f
Device Description
bandage and adhesive remover
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- 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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KOX | Solvent, Adhesive Tape | General, Plastic Surgery | 878.4730 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60494 | Patient medical adhesive remover | A liquid solvent intended for removal of medical adhesive/adhered devices (e.g., residual adhesive, adhesive tape, ostomy devices) from a patient’s skin. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00070048021657 | GS1 | ||||
| Package | 10070048021654 | GS1 | carton | 12 | In Commercial Distribution | |
| Package | 00070048221651 | GS1 | shrink wrap | 2 | In Commercial Distribution |