FDA UDI
In Commercial Distribution
🇺🇸 United States
Amerisource Bergen
DI: 00368001106603
·
Model: 10660
·
BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
168
Basic Information
- Brand Name
- Amerisource Bergen
- Primary DI
- 00368001106603
- Version / Model
- 10660
- Company Name
- BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
- Labeler DUNS
- 985523874
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 168
- Record Status
- Published
- Publish Date
- 2021-11-19
- Public Version
- 2
- Public Version Date
- 2022-04-25
- Public Version Status
- Update
- Public Device Record Key
- a71c4ad7-4ab5-47da-9365-c1afeed37411
Device Description
Microscope Cover Glass 22x22mm
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 | 00368001106603 | GS1 | ||||
| Unit of Use | 80368001106609 | GS1 | ||||
| Package | 20368001106607 | GS1 | Box | 5 | In Commercial Distribution | |
| Package | 60368001106605 | GS1 | Case | 100 | In Commercial Distribution |