FDA UDI
In Commercial Distribution
🇺🇸 United States
Micro-Scientific Goo Gone Topical and Surface Adhesive Remover
DI: 00739470000127
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Model: PK
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MICRO-SCIENTIFIC, LLC
Product Codes
1
GMDN Terms
2
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Micro-Scientific Goo Gone Topical and Surface Adhesive Remover
- Primary DI
- 00739470000127
- Version / Model
- PK
- Company Name
- MICRO-SCIENTIFIC, LLC
- Labeler DUNS
- 080214481
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-24
- Public Version
- 1
- Public Version Date
- 2022-09-01
- Public Version Status
- New
- Public Device Record Key
- c92d9a60-c499-4aff-9eb8-0c27b6610f4e
Device Description
Goo Gone 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 |
| 64150 | Medical device adhesive remover | A liquid solvent intended to remove residual adhesive from a medical device prior to decontamination/disinfection; it is not intended for patient contact. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10739470000124 | GS1 | Carton | 12 | In Commercial Distribution | |
| Primary | 00739470000127 | GS1 |