DEVICE: Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7" (B354OSRP57W0)

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Device Identifier (DI) Information

Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7"
OS-RP-57W
OS-RP-57W
ORANGE SURGICAL INSTRUMENTS, LLC
B354OSRP57W0
HIBCC
1
Retrieval Pouch-Rip Stop-W/Pull Strap - 5" x 7"
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
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No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN 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.
Insufflation gas conditioning tubing set A collection of sterile and non-sterile devices intended to be used with an insufflation gas conditioning system and/or a laparoscopic gas distention system, or other gas source, to condition the insufflation gas stream [typically carbon dioxide (CO2)] by heating and humidifying it before introduction into the peritoneal cavity or a wound during laparoscopic or open surgery. It is available in various configurations but typically includes a connection tube for connection to the gas source, an electrically-heated tube for transport of the conditioned gas to the operative site, a humidification chamber, a gas filter, and connectors. This is a single-use device.
Endoscopic electrosurgical handpiece/electrode, monopolar, reusable An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. This is a reusable device.
Endoscopic electrosurgical electrode, monopolar, single-use A sterile, invasive, distal component of an electrosurgical system intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It is a long thin device available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation; it does not include a handpiece with any form of electrical or mechanical controls (e.g., does not include controlling ring-handles). This is a single-use device.
Tissue extraction bag An impervious, flexible, sterile container intended to be used during minimally-invasive, typically keyhole, surgical techniques (e.g., laparoscopic) to extract dissected patient body tissue. The device is inserted into the body through a large bore cannula port, and the tissue to be extracted is placed in the bag with trans-cannula instruments and evacuated through the cannula. The device typically includes an x-ray detectable thread. This device may be used for surgical interventions such as an appendectomy, colonectomy, lymphadenectomy, or gallbladder removal. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
DWS Instruments, Surgical, Cardiovascular
GCJ Laparoscope, General & Plastic Surgery
HIF Insufflator, Laparoscopic
GEI Electrosurgical, Cutting & Coagulation & Accessories
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Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
November 15, 2016
November 15, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
B354OSRP57W10 10 B354OSRP57W0 2019-11-15 In Commercial Distribution
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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No Customer Contact currently defined
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