FDA UDI
In Commercial Distribution
🇺🇸 United States
CODED INTERMEDIATE MAGNIFICATION CHANGER
DI: 04582643134992
·
Model: IX3-CAS
·
EVIDENT CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- CODED INTERMEDIATE MAGNIFICATION CHANGER
- Primary DI
- 04582643134992
- Version / Model
- IX3-CAS
- Company Name
- EVIDENT CORPORATION
- Labeler DUNS
- 498178491
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-11
- Public Version
- 1
- Public Version Date
- 2022-04-19
- Public Version Status
- New
- Public Device Record Key
- 0f6a377d-d1e6-43d7-a804-6d1a9f0e3b3f
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
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MTX | Microscope And Microscope Accessories, Reproduction, Assisted | Obstetrics/Gynecology | 884.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17440 | Inverted-stage light microscope | A magnification instrument designed with illumination placed at the top with the stage (the specimen platform) below, and the optics on the bottom for microscopic study of large specimens by transmitted light. It is typically used in the laboratory for investigation and research. The device consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a specimen stage, a condenser to focus the light on the specimen, and a source of light. It is typically used for the examination of tissue cultures in all types of culture vessels (e.g., Petri dishes, culture bottles) and also in microtest and microtitre plates. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04582643134992 | GS1 | ||||
| Previous | 04953170413049 | GS1 |