DEVICE: SINGLE SITE CHOLE KIT 3 (20607915120874)

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Device Identifier (DI) Information

SINGLE SITE CHOLE KIT 3
CK103

APPLIED MEDICAL RESOURCES CORPORATION
20607915120874
GS1
1
Kit Contains: CY050, 5x38cm EPIX INLINE DISSCT 10/BX CB050, 5x38cm EPIX INLINE SCISSORS 10/BX CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

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

GMDN Preferred Term Name GMDN Definition
Laparoscopic multi-instrument access port, single-use A sterile sleeve assembly made of plastic materials intended to retract a small abdominal incision to allow multiple laparoscopic instruments to pass into the abdomen at the same time during a laparoscopic procedure. It will typically have an introducer that creates the abdominal incision (but is not used in cases where the surgeon chooses to make the incision), and a valve component that maintains the pneumoperitoneum established for the surgical procedure. It allows for the introduction of multiple instruments and/or a camera port, and removal of larger specimens during minimally-invasive laparoscopic surgery. 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.
Endoscopic electrosurgical handpiece/electrode, monopolar, single-use A sterile 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 single-use device.
Laparoscopic electrosurgical blunt dissector A sterile, rigid, laparoscopic device, covered with a sheath of electrical insulation, designed to perform through a compatible laparoscopic instrument (e.g., an access port) and to be connected to an electrosurgical diathermy generator when required to provide electrical current, to facilitate blunt dissection (e.g., hernia repair, cholecystectomy, colectomy) between tissue planes accessible via the abdominal cavity. It is a monopolar device typically constructed as a long insulated metal instrument whose distal end is equipped with a stainless steel scissors-like tip of various configurations operated through scissors-like ring handles at the proximal end. This is a single-use device.
Ligation clip, metallic A sterile, metallic, non-bioabsorbable clasp designed to be implanted around a blood vessel, lymphatic vessel, other tubular anatomy, or a tissue bundle for permanent occlusion. It may be used for ligation in open and endoscopic (e.g., laparoscopic) surgeries.
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FDA Product Code

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Product Code Product Code Name
GCJ Laparoscope, General & Plastic Surgery
HET Laparoscope, Gynecologic (And Accessories)
GEI Electrosurgical, Cutting & Coagulation & Accessories
FZP Clip, Implantable
MDM Instrument, Manual, Surgical, General Use
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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
October 09, 2015

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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
No Package DIs found
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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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1.949.713.8300
contact@appliedmedical.com
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