FDA UDI
In Commercial Distribution
🇺🇸 United States
MARK3
DI: D79659701
·
Model: 5970
·
CARGUS INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MARK3
- Primary DI
- D79659701
- Version / Model
- 5970
- Company Name
- CARGUS INTERNATIONAL, INC
- Labeler DUNS
- 096191093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-04
- Public Version
- 1
- Public Version Date
- 2021-10-12
- Public Version Status
- New
- Public Device Record Key
- 933f16bb-4667-41af-8386-00a4b7a32ece
Device Description
Endo Pulp Vitality Refrigerant Spray 6oz. Bottle - MARK3®
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
- Yes
- 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 |
|---|---|---|---|---|
| EAT | Tester, Pulp | Dental | 872.1720 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38787 | Cryogenic spray, dental | A liquid/gaseous refrigerant, typically contained in an aerosol or other spray dispenser, which is applied (sprayed) to a tooth to chill it, primarily to observe the patient's resulting intensity and duration of sensation in the evaluation of dental pulp vitality (i.e., helps to determine if the pulp is normal, inflamed, or necrotic). Some refrigerants may be used as a local anaesthetic when extracting deciduous teeth in children. 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 | D79659701 | HIBCC |