FDA UDI
In Commercial Distribution
🇺🇸 United States
MARK3
DI: D79690911
·
Model: 9091
·
CARGUS INTERNATIONAL, INC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
25
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- MARK3
- Primary DI
- D79690911
- Version / Model
- 9091
- Company Name
- CARGUS INTERNATIONAL, INC
- Labeler DUNS
- 096191093
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 25
- Record Status
- Published
- Publish Date
- 2017-04-14
- Public Version
- 3
- Public Version Date
- 2025-10-09
- Public Version Status
- Update
- Public Device Record Key
- 65d4532e-3a7f-4f13-a2bf-fbcf706aa179
Device Description
Etchant Gel 37% Bulk Pack 25/bx. (25x1.2ml. Syr. & 50 Tips) - MARK3
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
- 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 |
|---|---|---|---|---|
| KLE | Agent, Tooth Bonding, Resin | Dental | 872.3200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36153 | Dental tooth-etching solution | An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. 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 | D79690911 | HIBCC | ||||
| Unit of Use | D7969091 | HIBCC |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 50 – 77 Degrees Fahrenheit