DEVICE: CHOLE KIT 1 (20607915128832)

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Device Identifier (DI) Information

CHOLE KIT 1
GK307

APPLIED MEDICAL RESOURCES CORPORATION
20607915128832
GS1
1
Kit Contains: CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CTF73, 12x100 Kii Fios ZTHR 6/BX CTF03, 5x100 Kii Fios Z-THR 6/BX C0R95, 12x100 Kii BLUNT TIP SM CONE 6/BX CD001, 10mm RETRIEVAL SYSTEM, 10/BX CA090, DIRECT DRIVE LCA 3/BX
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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
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.
Laparoscopic irrigation/aspiration cannula A rigid, sterile, hand-operated, tube-like device intended to be inserted through a laparoscopic port to provide a conduit for the instillation and/or aspiration of fluid during laparoscopy. It has a single lumen, a proximal handle, and is typically made of plastic materials. It is connected via tubing to an appropriate irrigating/aspirating device(s), the irrigation/aspiration being regulated by the operator with mechanical valve controls typically in the handle of the cannula. 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 access cannula, single-use A sterile, single-lumen surgical device intended to be percutaneously inserted through the abdominal wall to create an access port for a laparoscope/laparoscopic instrument during laparoscopy. The cannula is often provided with a shut-off valve for gas/fluid supply, and other sealing devices (e.g., dedicated seals/rings, caps, valves), to prevent insufflation gas leakage whilst allowing entry of instruments. It may include a sharp or blunt trocar blade to assist introduction and/or puncture the abdominal wall; if the trocar is included it may be referred to as a trocar or trocar assembly. It is available in a variety of dimensions and/or designs. 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
FHF System, Evacuator, Fluid
HET Laparoscope, Gynecologic (And Accessories)
GCJ Laparoscope, General & Plastic Surgery
MDM Instrument, Manual, Surgical, General Use
FZP Clip, Implantable
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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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