FDA UDI
In Commercial Distribution
🇺🇸 United States
DentalJect Starter Kit - No Syringe Connector
DI: 00860010587393
·
Model: DJ06000-00
·
Vapocoolshot, Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- DentalJect Starter Kit - No Syringe Connector
- Primary DI
- 00860010587393
- Version / Model
- DJ06000-00
- Catalog Number
- DJ06000-00
- Company Name
- Vapocoolshot, Inc
- Labeler DUNS
- 032313444
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-11-07
- Public Version
- 1
- Public Version Date
- 2025-11-17
- Public Version Status
- New
- Public Device Record Key
- 565d5e40-7eb0-4239-8261-5bc2ff90024e
Device Description
DentalJect Starter Kit (No Syringe Connector), contains One DJ01000-00 DentalJect Applicator, one DJ03000-01 canister and one DJ03000-05 canister pack of 5
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
- Yes
- 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 |
|---|---|---|---|---|
| MLY | Vapocoolant Device | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46557 | Cold/cool therapy spray | A non-sterile liquid (e.g., alcohol based) in a spray container intended for localized application to the body surface to provide a cooling effect for underlying muscles/joints to reduce pain and swelling typically from sports injuries (cold therapy), and/or for cooling at the skin surface to treat heat rash or hot flushes (cool therapy); it may be intended to be applied to the skin directly or used in combination with a moist-cold pack/bandage (i.e., used to soak the moist-cold pack/bandage). After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860010587393 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243654 | 000 |