FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Midway Select
DI: 00843717103431
·
Model: 002-0364
·
MIDWAY DENTAL SUPPLY, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Midway Select
- Primary DI
- 00843717103431
- Version / Model
- 002-0364
- 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
- 2020-01-27
- Public Version
- 2
- Public Version Date
- 2023-04-03
- Public Version Status
- Update
- Public Device Record Key
- e47917af-0464-460c-ad92-f035e9e9a6d5
- Distribution End Date
- 2023-03-31
Device Description
Midway Select Refrigerant Spray - 6 oz
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
- 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 | 00843717103431 | GS1 |