FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 10304040109967
·
Model: 2020321
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
20
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 10304040109967
- Version / Model
- 2020321
- Catalog Number
- 2020321
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 20
- Record Status
- Published
- Publish Date
- 2019-11-01
- Public Version
- 1
- Public Version Date
- 2019-11-11
- Public Version Status
- New
- Public Device Record Key
- 961a02cc-67cc-4ae4-9876-ddcba265ede0
Device Description
OBTURATOR - OBT20 - SIZE 50 Obt 20pk -CHC5
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EKM | GUTTA-PERCHA | Dental | 872.3850 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47751 | Warm-bonded endodontic obturation system obturator | A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10304040109967 | GS1 | ||||
| Unit of Use | 00304040109960 | GS1 |