FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647022993
·
Model: 58054
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
50
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647022993
- Version / Model
- 58054
- Catalog Number
- 22030530
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 50
- Record Status
- Published
- Publish Date
- 2022-12-07
- Public Version
- 1
- Public Version Date
- 2022-12-15
- Public Version Status
- New
- Public Device Record Key
- e58e5b40-1407-46ce-9eec-9aea55acd095
Device Description
FSHRBRND HI MCROTOME BLDE 50PK
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 |
|---|---|---|---|---|
| IDL | MICROTOME, ACCESSORIES | Pathology | 864.3010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 42439 | Microtome blade IVD, reusable | A flat, wedge-shaped, sharp blade intended to be mounted into a microtome to cut micro-thin slices of tissue that may either be frozen or fixed, and usually impregnated, with paraffin wax. The resulting sections are mounted onto glass slides for staining and then viewing with a microscope. The cutting edge will typically need to be sharpened at intervals. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20613647022997 | GS1 | PACK | 1 | In Commercial Distribution | |
| Primary | 00613647022993 | GS1 | ||||
| Unit of Use | 10613647022990 | GS1 |
Customer Contacts
- Phone
- +1(724)517-2425
- [email protected]