FDA UDI
In Commercial Distribution
🇺🇸 United States
Hot Shot Elite Single Shot Assortment
DI: 00842326104143
·
Model: VP-0100
·
The Myerson Company Limited
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Hot Shot Elite Single Shot Assortment
- Primary DI
- 00842326104143
- Version / Model
- VP-0100
- Company Name
- The Myerson Company Limited
- Labeler DUNS
- 857278431
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 2
- Public Version Date
- 2018-03-29
- Public Version Status
- Update
- Public Device Record Key
- 3b032cbe-8ec0-408c-aa22-457537cd0078
Device Description
Variety pack (30 Single Shots) All three brands in one (Visiclear x2, Duracetal A1x1,A2x1,A3x1,A3.5x1,A4x1,B1x1,B2x1,B3x1,B4x1,C1x1,C2x1,C3x1,C4x1,D2x1,D3x1,D4x1,G1x1,G2x1,G3x1,P1x1,P2x1,P3x1, Duraflex DPx2,MPx2,Px2)
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EHP | Clasp, Preformed | Dental | 872.3285 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | Dental | 872.3760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58288 | Dental appliance fabrication material, thermoplastic | A thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00842326104143 | GS1 |
Customer Contacts
- Phone
- 18004232683
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 7 | Gram | |
| Weight | 8 | Gram |