FDA UDI
In Commercial Distribution
🇺🇸 United States
Globe Scientific
DI: 00840095604116
·
Model: 1411-20
·
GLOBE SCIENTIFIC INC.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
10
Basic Information
- Brand Name
- Globe Scientific
- Primary DI
- 00840095604116
- Version / Model
- 1411-20
- Company Name
- GLOBE SCIENTIFIC INC.
- Labeler DUNS
- 106793995
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2019-11-27
- Public Version
- 2
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- 2c21bb20-dcec-418e-9818-410533763d5a
Device Description
Microscope Cover Glass, 22mm x 40mm, # 2 Thickness, 1 oz./Vacuum Pack, 10 Packs/Box (10 oz.)
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 |
|---|---|---|---|---|
| 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 |
|---|---|---|---|---|---|---|
| Primary | 00840095604116 | GS1 | ||||
| Unit of Use | 00840095610520 | GS1 | ||||
| Package | 00840095604123 | GS1 | Case | 20 | In Commercial Distribution |