SteriGear
- Primary DI
- 10851616002011
- Brand
- SteriGear
- Company
- Sterigear, LLC
- Model
- RE4068P-01
- Device description
- Fig Leaf Foley Catheter Kit 16 Fr. 10274
- Published
- 2020-11-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- true
- Sterile
- true
- Single use
- true
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10851616002011 | Package | GS1 | 10 | In Commercial Distribution |
| 00851616002014 | Primary | GS1 | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Intermittent urethral catheterization kit, sterile | A collection of sterile devices that includes a urological catheter (with or without a urine drainage bag), a cap, and other related accessories intended for self-urinary catheterization. The catheter may be repeatedly inserted through the urethra by the user to provide short-term, episodic urine drainage. Because of the potential frequency of catheterization, the catheter will typically be pre-lubricated or coated with/made of materials that facilitate easy insertion and removal [e.g., polytetrafluoroethylene (PTFT) commonly known as Teflon, or glass], and possibly coated with an antibiotic to help prevent infection of the urinary tract. This is a reusable device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Special Storage Condition, Specify | 0 | 0 | Store at room temperature |
Contacts
| Phone | Email |
|---|
| +1(800)398-3259 | kpetersen@propellerinc.com |
Regulatory Flags
- DUNS number
- 809509297
- Device count
- 1
- DM exempt
- true
- Premarket exempt
- true
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- true
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company