FDA UDI
Not in Commercial Distribution
🇺🇸 United States
LEADER
DI: 00096295113709
·
Model: 3687456
·
Cardinal Health 110, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- LEADER
- Primary DI
- 00096295113709
- Version / Model
- 3687456
- Catalog Number
- 3687456
- Company Name
- Cardinal Health 110, Inc.
- Labeler DUNS
- 063997360
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-10-21
- Public Version
- 3
- Public Version Date
- 2023-03-08
- Public Version Status
- Update
- Public Device Record Key
- 9f3183c7-ef56-4f38-a46d-c33ac63d49e1
- Distribution End Date
- 2020-09-19
Device Description
LDR Tablet Cutter with Safety Shield 1 ea
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHY | Pill crusher/cutter | General Hospital | 880.6430 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 15750 | Pill crusher/splitter | A hand-held device designed for crushing or splitting in two medication in the form of a tablet for easier ingestion by a patient who cannot swallow the tablet whole. It is designed for convenience to be carried in the user's pocket or handbag (purse) and typically consists of several pieces that can be easily assembled by the user to crush or split the pill (tablet) by screwing the two main body parts against each other. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 50096295113704 | GS1 | CASE | 12 | Not in Commercial Distribution | 2020-09-19 |
| Package | 30096295113700 | GS1 | BOX | 6 | Not in Commercial Distribution | 2020-09-19 |
| Primary | 00096295113709 | GS1 |
Customer Contacts
- Phone
- +1(800)200-6313
- [email protected]