FDA UDI
In Commercial Distribution
🇺🇸 United States
Amalgam Catches
DI: 00723896009291
·
Model: 70-14420
·
PRACTICON, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
100
Basic Information
- Brand Name
- Amalgam Catches
- Primary DI
- 00723896009291
- Version / Model
- 70-14420
- Catalog Number
- 70-14420
- Company Name
- PRACTICON, INC.
- Labeler DUNS
- 119193803
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2018-07-11
- Public Version
- 1
- Public Version Date
- 2018-08-13
- Public Version Status
- New
- Public Device Record Key
- 50f266ad-c3b4-4617-ac0b-751351d51365
Device Description
Original Amalgam Catches "convert" a mouth mirror into a collection cup that helps prevent amalgam debris from falling down the throat. Plastic clip-on design reduces mirror fogging by shielding the glass from the patient's breath. Adds revenue by increasing valuable scrap recovery and recycling too
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
- 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 |
|---|---|---|---|---|
| EIF | Accessories, Retractor, Dental | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42333 | Dental amalgam trap | A device designed to prevent waste amalgam from entering a mains drainage system. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00723896009291 | GS1 | ||||
| Unit of Use | 00723896001004 | GS1 |