FDA UDI
In Commercial Distribution
🇺🇸 United States
Henry Schein
DI: 00304040003435
·
Model: 1024190
·
HENRY SCHEIN, INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
5
Basic Information
- Brand Name
- Henry Schein
- Primary DI
- 00304040003435
- Version / Model
- 1024190
- Catalog Number
- 1024190
- Company Name
- HENRY SCHEIN, INC.
- Labeler DUNS
- 012430880
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 5
- Record Status
- Published
- Publish Date
- 2018-09-24
- Public Version
- 1
- Public Version Date
- 2018-10-25
- Public Version Status
- New
- Public Device Record Key
- 8333917a-22f9-4192-b7fd-4939eb38aca1
Device Description
ETCH GEL EMPTY SYR REFILL
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
- 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 |
|---|---|---|---|---|
| EIC | SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35970 | Dental irrigation/aspiration syringe | A hand-held manual dental device (a plunger-type syringe) designed to inject and/or aspirate a volume of solution into the working area in the oral cavity. It typically consists of a small syringe (e.g., 3 ml) and is used for washing and aspirating the pulp cavity and root canal to remove debris. It is hand-operated by the user who exerts a steady pressure on, e.g., thumb rings and/or swivel finger bars, which exerts pressure on the syringe plunger forcing the washing/rinsing fluids through an attached needle (e.g., a blunt or very fine needle) directly at the operative site. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10304040003432 | GS1 | 200 | In Commercial Distribution | ||
| Primary | 00304040003435 | GS1 | ||||
| Unit of Use | 20304040003439 | GS1 |