FDA UDI
In Commercial Distribution
🇺🇸 United States
Fisherbrand
DI: 00613647028506
·
Model: 11002220
·
FISHER SCIENTIFIC COMPANY L.L.C.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
4
Basic Information
- Brand Name
- Fisherbrand
- Primary DI
- 00613647028506
- Version / Model
- 11002220
- Catalog Number
- 11002220
- Company Name
- FISHER SCIENTIFIC COMPANY L.L.C.
- Labeler DUNS
- 004321519
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 4
- Record Status
- Published
- Publish Date
- 2025-04-30
- Public Version
- 1
- Public Version Date
- 2025-05-08
- Public Version Status
- New
- Public Device Record Key
- 3a467490-58c0-40d1-b35a-39cbf2dc710c
Device Description
SAFECLEAR 1 XYL SUB 1GAL
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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KEM | AGENT, CLEARING | Pathology | 864.4010 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59122 | Xylene solution substitute IVD | A xylene substitute solution which may include d-limonene and/or hydrocarbon-based solutions, intended to be used alone or in combination with other IVDs in the processing, staining and/or testing of clinical laboratory specimens. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 20613647028500 | GS1 | CASE | 1 | In Commercial Distribution | |
| Primary | 00613647028506 | GS1 | ||||
| Unit of Use | 10613647028503 | GS1 |
Customer Contacts
- Phone
- +1(724)517-1500
- [email protected]