FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095644334
·
Model: 1376-20
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
100
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095644334
- Version / Model
- 1376-20
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 100
- Record Status
- Published
- Publish Date
- 2023-07-05
- Public Version
- 1
- Public Version Date
- 2023-07-13
- Public Version Status
- New
- Public Device Record Key
- 33116d42-13fa-484b-b353-653a26495433
Device Description
Microscope Slides, Diamond White Glass, 76 x 52mm (3" x 2"), 90° Ground Edges, Extra Large, Frosted, 2 Ends, 1 Side, 100 Slides/Box
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
- 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 | 00840095618786 | GS1 | CASE | 25 | In Commercial Distribution | |
| Primary | 00840095644334 | GS1 | ||||
| Unit of Use | 00840095687430 | GS1 |