FDA UDI
In Commercial Distribution
🇺🇸 United States
Sterilization Mirrors
DI: 00615375002407
·
Model: 31071
·
Kerr Corporation
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- Sterilization Mirrors
- Primary DI
- 00615375002407
- Version / Model
- 31071
- Company Name
- Kerr Corporation
- Labeler DUNS
- 199354556
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2017-08-31
- Public Version
- 3
- Public Version Date
- 2018-12-21
- Public Version Status
- Update
- Public Device Record Key
- 39202636-2cb0-4f27-8baa-a4a74b005096
Device Description
Autoclavable Dental Mirrors; Size #4 (13/16 Diameter) Sky Blue
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
- 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
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
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 | 00615375002407 | GS1 | ||||
| Unit of Use | 00615375007914 | GS1 |
Customer Contacts
- Phone
- +18005377123
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | No. 4 |