FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040107850
·
Model: 5701372
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
5
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040107850
- Version / Model
- 5701372
- Catalog Number
- 5701372
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2019-04-26
- Public Version
- 1
- Public Version Date
- 2019-05-06
- Public Version Status
- New
- Public Device Record Key
- b4ec0c64-ef18-4ef3-94a3-6986d3737dc6
Device Description
Titanium Post Introductory Kit. 4 x yellow size 0 titanium posts, 4 x red size 1 titanium posts, 4 x blue size 2 titanium posts; 1 x yellow size 0 primary reamer, 1 x red size 1 primary reamer, 1 x blue size 2 primary reamer; 1 x yellow size 0 secondary drill, 1 x red size 1 secondary drill, 1 x blue size 2 secondary drill; 1 x extender; 1 x internal wrench, 1 x external wrench; 1 x gauge card.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- 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
- 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 |
|---|---|---|---|---|
| ELR | POST, ROOT CANAL | Dental | 872.3810 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38609 | Root canal post, preformed | A prefabricated endodontic rod designed for insertion into the root canal of a patient to support and retain a crown prosthesis. It is typically a solid, cylindrical, metal (e.g., stainless steel, gold alloy) piece with a proximal end appropriate to support the crown on top; it is, however, available in a variety of shapes, dimensions, and materials (e.g., ceramics, fibre-reinforced polymers). In addition, it is available in a variety of types (e.g., non-threaded, pre-threaded, or self-tapping; straight or tapered). This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00304040107850 | GS1 | ||||
| Unit of Use | 10304040107857 | GS1 |