FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Midway Select
DI: 00843717108672
·
Model: 002-0607
·
MIDWAY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midway Select
- Primary DI
- 00843717108672
- Version / Model
- 002-0607
- Company Name
- MIDWAY DENTAL SUPPLY, LLC
- Labeler DUNS
- 102354446
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-10-12
- Public Version
- 2
- Public Version Date
- 2022-12-07
- Public Version Status
- Update
- Public Device Record Key
- b5207290-5ad0-465a-acb8-ab02693a1cb5
- Distribution End Date
- 2022-11-30
Device Description
Etch – Standard Package - 4 syringes + tips
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 etching solution | An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. 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 | 00843717108672 | GS1 |