FDA UDI
In Commercial Distribution
🇺🇸 United States
HistoCore PEGASUS
DI: 04049188216397
·
Model: 000000014048858005
·
Leica Biosystems Nussloch GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HistoCore PEGASUS
- Primary DI
- 04049188216397
- Version / Model
- 000000014048858005
- Catalog Number
- 14048858005
- Company Name
- Leica Biosystems Nussloch GmbH
- Labeler DUNS
- 315539452
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-11-02
- Public Version
- 2
- Public Version Date
- 2022-09-16
- Public Version Status
- Update
- Public Device Record Key
- f86652d5-dd68-4a66-8592-36d47860c7b4
Device Description
The HistoCore PEGASUS is an automated tissue processor specifically designed for fixation, dehydration, infiltration with intermedium and paraffin infiltration of human tissue specimens used for histological medical diagnosis by a pathologist, e.g. for cancer diagnosis. The HistoCore PEGASUS is designed for in vitro diagnostic applications.
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 | 04049188216397 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify