FDA UDI
In Commercial Distribution
🇺🇸 United States
CVS Health
DI: 00050428270691
·
Model: SQN5417SB1
·
WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
2
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Basic Information
- Brand Name
- CVS Health
- Primary DI
- 00050428270691
- Version / Model
- SQN5417SB1
- Company Name
- WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
- Labeler DUNS
- 062312574
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 2
- Record Status
- Published
- Publish Date
- 2024-04-16
- Public Version
- 1
- Public Version Date
- 2024-04-24
- Public Version Status
- New
- Public Device Record Key
- 23fc3bda-32e3-4ae1-891f-90f838b6eebb
Device Description
Dental Guards For Nighttime Teeth Grinding (Bruxism) Contains: 2 Dental Guards, 1 Storage Case, 1 Fitting Tray
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OBR | Mouthguard, Over-The-Counter | Unknown | U |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38621 | Mouthguard, reusable | A prefabricated oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during endoscopic diagnostic procedures, contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 10050428270698 | GS1 | ||||
| Primary | 00050428270691 | GS1 | ||||
| Package | 20050428270695 | GS1 | Shipper | 6 | In Commercial Distribution |