FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica ASP300 S
DI: 04049188055965
·
Model: 000000014047643515
·
Leica Biosystems Nussloch GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Leica ASP300 S
- Primary DI
- 04049188055965
- Version / Model
- 000000014047643515
- Catalog Number
- 14047643515
- Company Name
- Leica Biosystems Nussloch GmbH
- Labeler DUNS
- 315539452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-12-04
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- 2ee81f15-e304-44b6-adc7-125979523923
Device Description
The instrument has been designed so that it is safe to use by the operator as well as for process¬ing specimens – provided that it is operated according to the present Instructions for Use. The Leica ASP300 S is a modular tissue processor for the following laboratory applications: • Fixation • Dehydration • Paraffin infiltration of histological tissue specimens.
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 |
|---|---|---|---|---|
| IEO | PROCESSOR, TISSUE, AUTOMATED | Pathology | 864.3875 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57859 | Tissue processor IVD, automated/semi-automated | An electrically-powered automated or semi-automated laboratory instrument intended to be used for the processing of clinical tissue specimens [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination. The device may be a single unit or modular assembly. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04049188055965 | GS1 |
Customer Contacts
- Phone
- +4962241430
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify