FDA UDI
In Commercial Distribution
🇺🇸 United States
Zeiss SteREO Discovery
DI: 04064897000037
·
Model: SteREO Discovery.V8
·
Carl Zeiss Microscopy GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Zeiss SteREO Discovery
- Primary DI
- 04064897000037
- Version / Model
- SteREO Discovery.V8
- Catalog Number
- 435000-0000-000
- Company Name
- Carl Zeiss Microscopy GmbH
- Labeler DUNS
- 537598935
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 1
- Public Version Date
- 2022-10-06
- Public Version Status
- New
- Public Device Record Key
- 1a7857e9-7a5f-4370-a8a1-f7d95273c19f
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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| MTX | Microscope and microscope accessories, reproduction, assisted | Obstetrics/Gynecology | 884.6190 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17439 | Stereo light microscope | A magnification instrument designed with a standard microscope configuration with the object viewed through two observation objectives and oculars from above to provide a three-dimensional (3-D) view of the object under low magnification by transmitted light (typically no more than 60x). It is used in laboratories and for research, particularly for dissection, and 3-D viewing of large or living specimens. It consists of a stand that supports the main components, an ocular body in which the eyepieces are mounted, a nosepiece to support the objectives, a specimen stage, a condenser to focus the light on the specimen, and a source of light [e.g., tungsten (W), halogen] and light port. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04064897000037 | GS1 |
Customer Contacts
- Phone
- +493641644020
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius