FDA UDI
In Commercial Distribution
🇺🇸 United States
Tissue-Tek VIP®
DI: 00615233080165
·
Model: 5991
·
SAKURA FINETEK U.S.A., INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tissue-Tek VIP®
- Primary DI
- 00615233080165
- Version / Model
- 5991
- Catalog Number
- 5991
- Company Name
- SAKURA FINETEK U.S.A., INC.
- Labeler DUNS
- 179135769
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-12-15
- Public Version
- 1
- Public Version Date
- 2019-12-23
- Public Version Status
- New
- Public Device Record Key
- cebada1c-d36a-4b5e-87fb-656c5cc23f50
Device Description
Fixative, 5 Gallon Cube
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
- Yes
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IFP | FORMALIN, NEUTRAL BUFFERED | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57755 | 10% Formaldehyde solution IVD | A 10% formaldehyde solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00615233080165 | GS1 |
Customer Contacts
- Phone
- +1(310)972-7800
- [email protected]