FDA UDI
In Commercial Distribution
🇺🇸 United States
Rowley Biochemical Formalin Alcohol Acetic Acid
DI: F119852042008
·
Model: 1
·
TRANSENE COMPANY, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Rowley Biochemical Formalin Alcohol Acetic Acid
- Primary DI
- F119852042008
- Version / Model
- 1
- Catalog Number
- F-119
- Company Name
- TRANSENE COMPANY, INC.
- Labeler DUNS
- 044815983
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-09-13
- Public Version
- 1
- Public Version Date
- 2019-09-23
- Public Version Status
- New
- Public Device Record Key
- 8ac63575-4edb-4b07-a4ec-484c96b03774
Device Description
Formalin Alcohol Acetic Acid Solution (FAA)
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
- No
- 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 |
|---|---|---|---|---|
| IGF | Solution, Formalin-Alcohol-Acetic Acid | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 57759 | 10% Neutral buffered formalin (alcoholic) IVD | A 10% neutral buffered formalin (alcoholic) solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | F119852042008 | HIBCC |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Total Volume | 1 | Gallon | |
| Total Volume | 1 | Quart | |
| Total Volume | 1 | Pint | |
| Total Volume | 8 | Fluid Ounce | |
| Total Volume | 4 | Fluid Ounce |