FDA UDI
In Commercial Distribution
🇺🇸 United States
Leica Biosystems
DI: 20849832025430
·
Model: 3802631T
·
Leica Biosystems Richmond, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
800
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Basic Information
- Brand Name
- Leica Biosystems
- Primary DI
- 20849832025430
- Version / Model
- 3802631T
- Company Name
- Leica Biosystems Richmond, Inc.
- Labeler DUNS
- 082930884
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 800
- Record Status
- Published
- Publish Date
- 2024-04-04
- Public Version
- 1
- Public Version Date
- 2024-04-12
- Public Version Status
- New
- Public Device Record Key
- c964351a-8192-4334-a246-8c97ae10bbf7
Device Description
WHITE PRELOAD II TAPED ROUTINE Cassettes (800/CS)
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 | 00849832025436 | GS1 | ||||
| Primary | 20849832025430 | GS1 |
Customer Contacts
- Phone
- +1(866)4783999
- [email protected]
- Phone
- +1(800)5374669
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify |
Storage Conditions
- Type
- Special Storage Condition, Specify