FDA UDI
In Commercial Distribution
🇺🇸 United States
LW Scientific, Inc
DI: 00664816003657
·
Model: CPL-FXDR-10S3
·
LW SCIENTIFIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LW Scientific, Inc
- Primary DI
- 00664816003657
- Version / Model
- CPL-FXDR-10S3
- Catalog Number
- CPL-FXDR-10S3
- Company Name
- LW SCIENTIFIC, INC.
- Labeler DUNS
- 785335381
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-31
- Public Version
- 1
- Public Version Date
- 2020-06-08
- Public Version Status
- New
- Public Device Record Key
- 93c31857-adb4-4002-b491-6b280ec1ff29
Device Description
CytoPrep 10, 10 slide, heat fix and dry, 90-240v AC adapter
Device Characteristics
- Single Use
- No
- 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
- Yes
- 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 |
|---|---|---|---|---|
| IEG | Table, Slide Warming | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17134 | Microscope slide dryer | A mains electricity (AC-powered) device typically used in the laboratory to dry many microscope specimen slides that have been treated, e.g., coated and/or stained with specimen material. This device will advance the drying time of the coating/solution/stain placed on the slide so that it can be further handled with safety to both the specimen and the user. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00664816003657 | GS1 |