FDA UDI
In Commercial Distribution
🇺🇸 United States
Epredia
DI: 05051663626071
·
Model: Laser Embedding Cassettes - White
·
SHANDON DIAGNOSTICS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1000
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Basic Information
- Brand Name
- Epredia
- Primary DI
- 05051663626071
- Version / Model
- Laser Embedding Cassettes - White
- Catalog Number
- 110-01-10LMI
- Company Name
- SHANDON DIAGNOSTICS LIMITED
- Labeler DUNS
- 219103512
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1000
- Record Status
- Published
- Publish Date
- 2026-03-11
- Public Version
- 1
- Public Version Date
- 2026-03-19
- Public Version Status
- New
- Public Device Record Key
- 1940d7ea-5b4b-469d-a36c-308b0cb7f2c7
Device Description
Stripped stacks, 25x40mm
Device Characteristics
- Single Use
- Yes
- 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
- 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 |
|---|---|---|---|---|
| IDZ | Cassettes, Tissue | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62970 | Histology tissue cassette IVD, laboratory processing, single-use | A small device intended to be used in the laboratory to support/contain clinical tissue specimens (e.g., biopsy samples) to facilitate specimen processing [e.g., fixation (encapsulation in paraffin wax), dehydration, infiltration] in preparation for subsequent cytological or histological examination, and storage. It is in the form of a plastic container, with or without a lid, with drainage holes to maximize fluid exposure during tissue submersion in a parent device into which the container is loaded. It may, in addition, include a fenestrated insert to hold and prevent the loss of a smaller specimens. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | 05051663626927 | GS1 | ||||
| Primary | 05051663626071 | GS1 |