FDA UDI
In Commercial Distribution
🇺🇸 United States
Crystal HD® Mouth Mirrors
DI: 10840161306019
·
Model: 50Z372G
·
ZIRC DENTAL PRODUCTS, INC.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
12
Basic Information
- Brand Name
- Crystal HD® Mouth Mirrors
- Primary DI
- 10840161306019
- Version / Model
- 50Z372G
- Company Name
- ZIRC DENTAL PRODUCTS, INC.
- Labeler DUNS
- 064783913
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 12
- Record Status
- Published
- Publish Date
- 2022-10-05
- Public Version
- 1
- Public Version Date
- 2022-10-13
- Public Version Status
- New
- Public Device Record Key
- 1ebdeeff-8170-4af6-a444-dbf59ff7035c
Device Description
Resin Screw-on heads 12 pk #5 Beige, 40% brighter than rhodium mirrors, Lens is flush with mirror frame, eliminating the possibility of corrosion build-up, Cone Socket
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 10840161306019 | GS1 | ||||
| Unit of Use | 00840161306012 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 24 | Micrometer |