FDA UDI
In Commercial Distribution
🇺🇸 United States
GUM
DI: 00070942007504
·
Model: KIT57
·
SUNSTAR AMERICAS, INC.
Product Codes
3
GMDN Terms
3
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GUM
- Primary DI
- 00070942007504
- Version / Model
- KIT57
- Company Name
- SUNSTAR AMERICAS, INC.
- Labeler DUNS
- 025066358
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-10-04
- Public Version
- 1
- Public Version Date
- 2024-10-14
- Public Version Status
- New
- Public Device Record Key
- c5e3dc99-fbd2-4ed9-96a8-bc79bf449414
Device Description
135RA1 Multi-Clean Toothbrush 828PQ Twisted Mint® Floss Picks sample pack 649PA Soft-Picks® Advanced Tight sample pack
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- Kit
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JES | Floss, Dental | Dental | 872.6390 | 1 |
| EFW | Toothbrush, Manual | Dental | 872.6855 | 1 |
| JET | Pick, Massaging | Dental | 872.6650 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 11158 | Dental floss | A string-like device formed as thread or tape, used for the removal of plaque and/or debris from the proximal surfaces of teeth and the gingival surfaces of fixed prostheses. It is typically made of a synthetic fibre. After application, this device cannot be reused. | No | Active |
| 31817 | Basic manual toothbrush | An instrument designed to be used by a patient to manually brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device is typically used with toothpaste. This is a reusable device. | No | Active |
| 33208 | Periodontal pick/brush, reusable | A manual, pointed, oral hygiene device with a soft tip or bristles intended to be used to stimulate and massage the gums to promote good periodontal (gum) condition, and to clean and remove plaque and debris from between the teeth and gingival surfaces. It may also be referred to as an interdental/interproximal brush and is intended for use in the home. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00070942007504 | GS1 |