FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647023945
·
Model: M492-7FS
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1500
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647023945
- Version / Model
- M492-7FS
- Catalog Number
- 15182701F
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1500
- Record Status
- Published
- Publish Date
- 2022-11-29
- Public Version
- 1
- Public Version Date
- 2022-12-07
- Public Version Status
- New
- Public Device Record Key
- 3738950e-86ef-4992-95fe-1a0d2f3aca72
Device Description
FB HISTOSETTE II PCH 1500/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
- Yes
- 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 |
|---|---|---|---|---|
| 63791 | Tissue embedding mould IVD, single-use | A plastic container of square or rectangular shape intended to be used to embed tissue specimens into an embedding medium (e.g., paraffin wax) to form a solid block, which is subsequently cut into thin sections for processing and analysis of the tissue specimen. It is typically made of synthetic polymer materials (e.g., plastic) This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20613647023949 | GS1 | case | 1 | In Commercial Distribution | |
| Primary | 00613647023945 | GS1 | ||||
| Unit of Use | 10613647023942 | GS1 |
Customer Contacts
- Phone
- +1(724)517-2425
- [email protected]