FDA UDI
In Commercial Distribution
🇺🇸 United States
Microscope Slides
DI: 00812269032872
·
Model: ES0201T
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
72
Basic Information
- Brand Name
- Microscope Slides
- Primary DI
- 00812269032872
- Version / Model
- ES0201T
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2022-11-21
- Public Version
- 1
- Public Version Date
- 2022-11-29
- Public Version Status
- New
- Public Device Record Key
- e49f2e5e-41aa-456d-80bc-09ff286ad819
Device Description
Economy Microscope Slides, 90° Ground Edges, Tan Frosted
Device Characteristics
- Single Use
- Yes
- 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 |
|---|---|---|---|---|
| KEW | Slides, Microscope | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57925 | General specimen microscopy slide IVD, single-use | A glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 10812269032879 | GS1 | Case | 20 | In Commercial Distribution | |
| Primary | 00812269032872 | GS1 | ||||
| Unit of Use | 00812269032865 | GS1 |