FDA UDI
In Commercial Distribution
🇺🇸 United States
A-dec
DI: 10194665001971
·
Model: 23.0872.00
·
A-DEC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
Basic Information
- Brand Name
- A-dec
- Primary DI
- 10194665001971
- Version / Model
- 23.0872.00
- Catalog Number
- 23.0872.00
- Company Name
- A-DEC, INC.
- Labeler DUNS
- 009617473
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-15
- Public Version
- 1
- Public Version Date
- 2022-08-23
- Public Version Status
- New
- Public Device Record Key
- 52e91c8c-a0e1-4a16-87fc-cb141bb520a1
Device Description
Syringe Tip,Laser Etch
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
- No
- PM Exempt
- No
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 |
|---|---|---|---|---|
| 45131 | Dental delivery system irrigation handpiece | A hand-held device that is used to regulate and direct a stream of pressurized, warmed water and/or air for the purpose of irrigating/clearing debris from the field of operation in the oral cavity during restorative or operative dental procedures. It is fitted with a long syringe-like nozzle that is activated by the user, typically through push-type controls. This device, also commonly known as a three-way or a Triplex syringe, is typically a component of a dental delivery system from which the air and water is supplied. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20194665001978 | GS1 | 2 | In Commercial Distribution | ||
| Primary | 10194665001971 | GS1 | ||||
| Package | 30194665001975 | GS1 | 5 | In Commercial Distribution | ||
| Package | 40194665001972 | GS1 | 25 | In Commercial Distribution |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K931137 | 000 |