FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040108915
·
Model: 5701409
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
72
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040108915
- Version / Model
- 5701409
- Catalog Number
- 5701409
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2019-02-07
- Public Version
- 1
- Public Version Date
- 2019-03-11
- Public Version Status
- New
- Public Device Record Key
- f21d48c2-80a3-4362-9f99-1dc0f92236c9
Device Description
Acclean Gentle Pick
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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| 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 |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20304040108912 | GS1 | 12 | In Commercial Distribution | ||
| Primary | 10304040108915 | GS1 | ||||
| Unit of Use | 00304040108918 | GS1 |