FDA UDI
In Commercial Distribution
🇺🇸 United States
SCOTT'S EASY DISPENSER EXTRUDER CARTRIDGE GUN 50mL
DI: D77810482100
·
Model: 104-8210
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- SCOTT'S EASY DISPENSER EXTRUDER CARTRIDGE GUN 50mL
- Primary DI
- D77810482100
- Version / Model
- 104-8210
- Catalog Number
- 104-8210
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-02-27
- Public Version
- 1
- Public Version Date
- 2021-03-08
- Public Version Status
- New
- Public Device Record Key
- f2ad38b0-b9e4-49be-a8d8-2234e3646e66
Device Description
DISPENSING GUN: EASY (1/pack) Compatible with: 50 mL cartridges; For more information: https://www.scottsdental.com/catalog/product/view/id/23782/s/cartridge-dispensing-gun-scott-s-select/
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| EID | SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35860 | Dental impression material syringe, reusable | A non-sterile hand-held manual dental instrument designed to inject impression material into an impression tray or directly into a patient's mouth. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | D77810482100 | HIBCC |
Customer Contacts
- Phone
- +1(800)901-3368
- [email protected]