DEVICE: B. MOLINELLI, MD GS LAP KIT (30607915129737)

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Device Identifier (DI) Information

B. MOLINELLI, MD GS LAP KIT
CK392

APPLIED MEDICAL RESOURCES CORPORATION
30607915129737
GS1
1
Kit Contains: CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX CNGL2, GelPOINT ADVANCED ACCESS PLATFORM CB040, 5mmx45cm EPIX® LAPA SCISSOR, 10/BX CY020, 5mmX45cm EPIX® LAPA DISSECT, 10/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
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 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.
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
GEI Electrosurgical, Cutting & Coagulation & Accessories
HET Laparoscope, Gynecologic (And Accessories)
GCJ Laparoscope, General & Plastic Surgery
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 16, 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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1.949.713.8300
contact@appliedmedical.com
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