Wallace SurePro Embryo Replacement Catheter w/ Stylet
- Primary DI
- 30888937021272
- Company
- Coopersurgical, Inc.
- Model
- PPS623
- Device description
- Wallace SurePro Embryo Replacement Catheter w/ Stylet, Soft 23cm (Box of 10)
- Published
- 2019-12-04
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Regulatory Flags
- DUNS number
- 801895244
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- 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
- false
- No natural rubber latex
- true
- Sterilization required before use
- false
Identifiers
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 20888937021275 | Package | GS1 | 10 | In Commercial Distribution |
| 30888937021272 | Package | GS1 | 10 | In Commercial Distribution |
| 00888937021271 | Primary | GS1 | 0 | |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Package type | Contains DI | Discontinue date | Status |
|---|
| 20888937021275 | Package | GS1 | 10 | Box | 00888937021271 | | In Commercial Distribution |
| 30888937021272 | Package | GS1 | 10 | Case | 20888937021275 | | In Commercial Distribution |
| 00888937021271 | Primary | GS1 | 0 | | | | |
Product Codes
| Code | Name | Class | Specialty | Regulation | Implant | Malfunction reporting |
|---|
| MQG | Accessory, Assisted Reproduction | 2 | Obstetrics/Gynecology | 884.6120 | N | Eligible |
Premarket Submissions
No records found.
Premarket Details
No records found.
GMDN Terms
| Term | Definition |
|---|
| Assisted reproduction transfer catheter/set | A device or collection of devices that includes a flexible polymer tube intended to be used primarily to transfer gametes (eggs or sperm) and/or embryos into the female reproductive tract for the purpose of assisted reproduction [e.g., intrauterine insemination (IUI) or gamete intrafallopian transfer (GIFT)]. In addition to the ‘live transfer’ catheter it may also include a trial transfer catheter intended to assess/ensure that embryo placement will be successful; it typically also includes devices intended to assist catheter introduction (e.g., outer guide sheath, stylet). This is a single-use device. |
Device Sizes
| Type | Value | Text |
|---|
| Catheter Length | 23 Centimeter | |
Storage And Handling
No records found.
Contacts
No records found.
Other Devices From This Company
Other Devices Sharing Product Codes