FDA UDI
In Commercial Distribution
🇺🇸 United States
GluGone Adhesive Remover, 0.67 oz.
DI: 00854137001733
·
Model: GG80148
·
CHEMENCE MEDICAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- GluGone Adhesive Remover, 0.67 oz.
- Primary DI
- 00854137001733
- Version / Model
- GG80148
- Catalog Number
- GG80148
- Company Name
- CHEMENCE MEDICAL PRODUCTS, INC.
- Labeler DUNS
- 079163089
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-27
- Public Version
- 1
- Public Version Date
- 2022-07-05
- Public Version Status
- New
- Public Device Record Key
- 9cf02d49-2716-43bb-998e-069c1398c9b8
Device Description
0.67 OZ
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
- 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
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Package | 10854137001730 | GS1 | Box | 48 | In Commercial Distribution | |
| Primary | 00854137001733 | GS1 |
Customer Contacts
- Phone
- 18446334583
- [email protected]