FDA UDI
Not in Commercial Distribution
🇺🇸 United States
Zeiss Axio Observer
DI: 04064897000082
·
Model: Axio Observer 7
·
Carl Zeiss Microscopy GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Zeiss Axio Observer
- Primary DI
- 04064897000082
- Version / Model
- Axio Observer 7
- Catalog Number
- 431007-9904-000
- Company Name
- Carl Zeiss Microscopy GmbH
- Labeler DUNS
- 537598935
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-09-28
- Public Version
- 2
- Public Version Date
- 2024-10-11
- Public Version Status
- Update
- Public Device Record Key
- 4d04e873-ce85-44cf-8480-8e6af1d6e5db
- Distribution End Date
- 2024-09-17
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 |
|---|---|---|---|---|
| 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 | 04064897000082 | GS1 |
Customer Contacts
- Phone
- +493641644020
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius