FDA UDI
In Commercial Distribution
🇺🇸 United States
Channels
DI: 10304040162252
·
Model: 2020621
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
60
Basic Information
- Brand Name
- Channels
- Primary DI
- 10304040162252
- Version / Model
- 2020621
- Catalog Number
- 2020621
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 60
- Record Status
- Published
- Publish Date
- 2022-08-05
- Public Version
- 1
- Public Version Date
- 2022-08-15
- Public Version Status
- New
- Public Device Record Key
- 1f7698e6-8e67-491d-a64c-452ab36bc36f
Device Description
Channels Flex Gutta Percha Points 40.06
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
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKS | FILE, PULP CANAL, ENDODONTIC | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45412 | Chloroform gutta-percha | A dental material made from the coagulated sap of certain tropical trees, that is dissolved in chloroform and intended to fill/seal the root canal of a tooth. It may also be used to soften natural gutta-percha based points. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 00304040162255 | GS1 | ||||
| Primary | 10304040162252 | GS1 |