Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7"
- Primary DI
- B354OSRP57W10
- Brand
- Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7"
- Company
- ORANGE SURGICAL INSTRUMENTS, LLC
- Model
- OS-RP-57W
- Catalog number
- OS-RP-57W
- Device description
- Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7"
- Published
- 2016-11-15
- Public version status
- Update
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| DWS | Instruments, Surgical, Cardiovascular |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| DWS | Instruments, Surgical, Cardiovascular | Cardiovascular | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| B354OSRP57W10 | Package | HIBCC | 10 | Not in Commercial Distribution |
| B354OSRP57W0 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Laparoscopic wound closure thread | A sterile, bioabsorbable, implantable, device intended to be used exclusively during laparoscopic surgery to approximate subcutaneous tissue after removal of the laparoscopic sleeve/port. It consists of a suture with an attached short tag (anchor), and often includes a plastic guide which can take different forms depending on the method of laparoscopic entry, and a metal (e.g., stainless steel) and/or plastic pusher. The guide and pusher are used to deliver the suture so that the tag is deep to the wound, with the suture trailing so that it can be ligated on removal of the laparoscopic sleeve/port. |
Regulatory Flags
- DUNS number
- 047063695
- 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
- false
- Sterilization required before use
- false
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