FDA UDI
In Commercial Distribution
🇺🇸 United States
Defend
DI: 00843471130803
·
Model: AW-1000
·
Young Innovations, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Defend
- Primary DI
- 00843471130803
- Version / Model
- AW-1000
- Catalog Number
- AW-1000
- Company Name
- Young Innovations, Inc.
- Labeler DUNS
- 004193103
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-30
- Public Version
- 1
- Public Version Date
- 2022-11-07
- Public Version Status
- New
- Public Device Record Key
- bc6de969-6f4b-4921-b1da-524ee90af569
Device Description
Disposable Air/Water Syringe Tip Clear
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
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| ECB | UNIT, SYRINGE, AIR AND/OR WATER | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 65430 | Dental delivery system irrigation handpiece tip | A rigid, tubular device intended to be fitted to the distal end of a dental delivery system irrigation handpiece (not included) to direct a stream of pressurized, warmed water and/or air to the field of operation in the oral cavity to irrigate/clear debris during a restorative or operative dental procedure. This is a single use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10843471130800 | GS1 | Bag | 250 | In Commercial Distribution | |
| Primary | 00843471130803 | GS1 | ||||
| Package | 20843471130807 | GS1 | Case | 48 | In Commercial Distribution |
Customer Contacts
- Phone
- +1 (800) 275-0020
- [email protected]