FDA UDI
In Commercial Distribution
🇺🇸 United States
Microscope Cover Glass
DI: 00812269038874
·
Model: MC0106
·
TYPENEX MEDICAL LLC
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- Microscope Cover Glass
- Primary DI
- 00812269038874
- Version / Model
- MC0106
- Company Name
- TYPENEX MEDICAL LLC
- Labeler DUNS
- 600850213
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-15
- Public Version
- 1
- Public Version Date
- 2022-11-23
- Public Version Status
- New
- Public Device Record Key
- 5e80b714-3f26-4d82-b061-2df8d0c6d172
Device Description
Microscope Cover Glass, 22mm x 22mm, # 1.5 Thickness
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 |
|---|---|---|---|---|
| KES | Coverslips, Microscope Slide | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15687 | Microscope slide coverslip IVD | A thin piece of glass or a plastic sheath placed over a specimen on a microscope slide, to serve as a physical barrier to protect the specimen from mechanical forces and environmental exposure. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 00810050851237 | GS1 | Case | 10 | In Commercial Distribution | |
| Primary | 00812269038874 | GS1 | ||||
| Package | 00810050851657 | GS1 | Master Carton | 20 | In Commercial Distribution |