Pink Ultra II Cartridge 8x50 ml
- Primary DI
- G599107C1
- Brand
- Pink Ultra II Cartridge 8x50 ml
- Company
- Jkr Laboratories, Inc.
- Model
- 107C
- Device description
- ear impression material
- Published
- 2024-02-12
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- true
Product Codes
| Code | Name |
|---|
| ESD | Hearing Aid, Air-Conduction, Prescription |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | Ear, Nose, Throat | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| G599107C1 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Earmould impression material | A rubber-like material used to replicate the shape of an individual's ear canal for the manufacture of custom-made hearing aids and earmoulds. The device may be supplied as a two-component silicone (base and catalyst) which produces the usable product. This is a single-use device. |
Regulatory Flags
- DUNS number
- 196376339
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| G599103B0 | Aqua Plus Bulk Blue | 103B | 103B | 2025-02-07 |
| G599103R0 | Aqua Plus Bulk Red | 103R | 103R | 2025-02-07 |
| G5991030 | Aqua Plus Kit | 103 | | 2024-02-12 |
| G599103D0 | Aqua Plus Single Red 2x8 g | 103D | | 2024-02-12 |
| G599103E0 | Aqua Plus Single Blue 2x8 g | 103E | | 2024-02-12 |
| G599107A1 | Blue Ultra Cartridge 8x50 ml | 107A | | 2024-02-12 |
| G5991080 | Gold Velvet II Impression Single 2x8 g | 108 | | 2024-02-12 |
| G599970 | Gold Velvet II 10 unit | 97 | | 2024-02-12 |
| G59997A0 | Gold Velvet II 40 unit | 97A | | 2024-02-12 |
| G59997B0 | Gold Velvet II 80 unit | 97B | | 2024-02-12 |
| G599980 | XL-300 Impression 660 g | 98 | | 2024-02-12 |
| G59998A0 | XL-300 Accelerator 25 g | 98A | | 2024-02-12 |
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