FDA UDI
In Commercial Distribution
🇺🇸 United States
HistoCore PELORIS
DI: 09349458005573
·
Model: HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit
·
LEICA BIOSYSTEMS MELBOURNE PTY LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HistoCore PELORIS
- Primary DI
- 09349458005573
- Version / Model
- HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit
- Catalog Number
- B45.5120
- Company Name
- LEICA BIOSYSTEMS MELBOURNE PTY LTD
- Labeler DUNS
- 753184944
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-30
- Public Version
- 1
- Public Version Date
- 2023-09-07
- Public Version Status
- New
- Public Device Record Key
- ff021a96-6b94-40c3-b212-682364425c8c
Device Description
HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit
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
- No
- Has Lot/Batch Number
- Yes
- 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 | 09349458005573 | GS1 |