Sklar
- Primary DI
- 10649111144929
- Brand
- Sklar
- Company
- SKLAR CORPORATION
- Model
- 67-7610
- Device description
- RYDEL-SEIFFER TUNE FRK C64/128
- Published
- 2019-03-12
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| MDM | INSTRUMENT, MANUAL, SURGICAL, GENERAL USE |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| MDM | Instrument, Manual, Surgical, General Use | General, Plastic Surgery | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 10649111144929 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized |
|---|
| 10649111144929 | 10649111144929 |
GMDN Terms
| Term | Definition |
|---|
| Urostomy bag kit | A collection of non-sterile devices intended to be used for attachment/replacement of a urostomy bag (for collecting urine following a urostomy procedure). It includes the urostomy bag, a base plate, and additional devices (e.g., towels, wipes, scissors) to allow for fitting of the bag/base plate to the patient and hygienic maintenance of the ostomy site (e.g., following leakage). This is a single-use device. |
Sterilization Methods
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags
- DUNS number
- 006966006
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- true
- Sterilization required before use
- true
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