FDA UDI
In Commercial Distribution
🇺🇸 United States
REMEL
DI: 00848838024399
·
Model: R21923
·
REMEL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- REMEL
- Primary DI
- 00848838024399
- Version / Model
- R21923
- Catalog Number
- R21923
- Company Name
- REMEL, INC.
- Labeler DUNS
- 065769564
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-12-23
- Public Version
- 1
- Public Version Date
- 2023-01-02
- Public Version Status
- New
- Public Device Record Key
- 8737a6d4-6451-4cdf-a88b-8d5d5e23a6aa
Device Description
Formalin 10% (15ml Vial) PK/120
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
- No
- 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 |
|---|---|---|---|---|
| 57758 | Neutral buffered formalin IVD | A neutral buffered formalin solution intended to be used as a fixative in the processing of biological tissues or clinical specimens. Some formulations may contain additional components such as zinc, alcohol, and/or eosin. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00848838024399 | GS1 |