FDA UDI
In Commercial Distribution
🇺🇸 United States
Scott's Select Mouth Mirror Front Surface #5
DI: D77810320051
·
Model: 103-2005
·
SCOTT'S DENTAL SUPPLY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Scott's Select Mouth Mirror Front Surface #5
- Primary DI
- D77810320051
- Version / Model
- 103-2005
- Catalog Number
- 103-2005
- Company Name
- SCOTT'S DENTAL SUPPLY L.L.C.
- Labeler DUNS
- 137217043
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2024-09-05
- Public Version
- 1
- Public Version Date
- 2024-09-13
- Public Version Status
- New
- Public Device Record Key
- abcca876-4156-4df2-9e90-f393e9369e75
Device Description
Size 5 front surface mirrors coated with rhodium for clear, ghost-free image and maximum reflection. Used with cone socket style mirror handles. Autoclavable and cold sterilizable. For more information visit: https://www.scottsdental.com/mouth-mirrors-fs-scotts.html?queryID=e7ae60a117131fcd7a9f4f386d1dcaef&objectID=29676&indexName=magento2_production_default_products
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
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization, Liquid Chemical
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EAX | Mirror, Mouth | Dental | 872.4565 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 31776 | Dental mirror, reusable | A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. 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 | D77810320050 | HIBCC | ||||
| Primary | D77810320051 | HIBCC |
Customer Contacts
- Phone
- 800-901-3368
- [email protected]