FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica CV5030-TS5015
DI: 04049188001948
·
Model: 149CVTS5015
·
Leica Biosystems Nussloch GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica CV5030-TS5015
- Primary DI
- 04049188001948
- Version / Model
- 149CVTS5015
- Catalog Number
- 149CVTS5015
- Company Name
- Leica Biosystems Nussloch GmbH
- Labeler DUNS
- 315539452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-16
- Public Version
- 2
- Public Version Date
- 2020-08-20
- Public Version Status
- Update
- Public Device Record Key
- c8e1b56a-2f05-4e21-b4b3-a3c38174b67c
Device Description
The Leica CV5030 is a robotic coverslipper for coverslipping tissue sections, cells or swabs mounted on specimen slides with cover slips made out of glass using a wide variety of differ¬ent cover slip mountants. It may only be used with instrument accessories approved by Leica Biosystems Nussloch GmbH.
Device Characteristics
- Single Use
- No
- 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
- Yes
- Has Lot/Batch Number
- No
- 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 |
|---|---|---|---|---|
| KIM | DEVICE FOR SEALING MICROSECTIONS | Pathology | 864.3400 | 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 | 04049188001948 | GS1 |
Customer Contacts
- Phone
- +4962241430
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify