FDA UDI
In Commercial Distribution
🇺🇸 United States
LabChoice Microscope Slides, Double Frosted, Ground Corners
DI: 00840117337275
·
Model: 4178
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
72
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Basic Information
- Brand Name
- LabChoice Microscope Slides, Double Frosted, Ground Corners
- Primary DI
- 00840117337275
- Version / Model
- 4178
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 72
- Record Status
- Published
- Publish Date
- 2024-06-24
- Public Version
- 3
- Public Version Date
- 2024-10-10
- Public Version Status
- Update
- Public Device Record Key
- baa0e699-e138-4a0e-88d8-e82848da227c
Device Description
3" x 1" x 1mm
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
- Yes
- 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 |
|---|---|---|---|---|
| KEW | Slides, Microscope | 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 |
|---|---|---|---|---|---|---|
| Unit of Use | 00810180840064 | GS1 | ||||
| Primary | 00840117337275 | GS1 | ||||
| Package | 00840117334939 | GS1 | Case | 20 | In Commercial Distribution |