FDA UDI
In Commercial Distribution
🇺🇸 United States
A.S.A.P.® Indirect+ Extraoral/HP Disc Adjuster Refill
DI: 07540172017008
·
Model: 130945
·
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- A.S.A.P.® Indirect+ Extraoral/HP Disc Adjuster Refill
- Primary DI
- 07540172017008
- Version / Model
- 130945
- Catalog Number
- 130945
- Company Name
- CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
- Labeler DUNS
- 626406016
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-06-05
- Public Version
- 3
- Public Version Date
- 2020-03-23
- Public Version Status
- Update
- Public Device Record Key
- dd5ca6d3-19b9-4f7c-96bd-8647e6781b9b
Device Description
Dental Abrasive Disk
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
- 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 |
|---|---|---|---|---|
| EHJ | DISK, ABRASIVE | Dental | 872.6010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 35807 | Dental abrasive disk, reusable | A dental instrument consisting of a circular flat or slightly conical sheet carrying or containing an abrasive, intended to perform a circular and/or oscillatory motion for polishing and finishing a cavity preparation and/or for cutting or polishing dental restorations. It is designed to be fixed at its centre to a mandrel and intended to be used with a dental power tool handpiece (e.g., straight or contra-angle). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07540172017008 | GS1 |
Customer Contacts
- Phone
- +1(800)265-3444
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 13 | Millimeter | |
| Device Size Text, specify | 3 x 13mm adjusters |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store at room temperature
- Type
- Storage Environment Temperature
- Temperature Range
- High: 25 Degrees Celsius