DEVICE: KE089 BASICO COLE (20607915131191)

Device Identifier (DI) Information

KE089 BASICO COLE
GK238
In Commercial Distribution

APPLIED MEDICAL RESOURCES CORPORATION
20607915131191
GS1

1
187129135 *Terms of Use
Kit Contains: C2201, 120MM INSUFF NEEDLE XE, 20/BX CTS12, 11x100 Kii SLEEVE ZTHR 12/BX CA090, DIRECT DRIVE LCA 3/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C4130, 5mmx35cm EPIX LAPA GRASPER, 10/BX CTB12, 5x100 Kii SH BLD ZTHR DP 10/BX CTB33, 11X100 Kii SH BLD ZTHR 6/BX
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Device Characteristics

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

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
57956 Rigid endoscopic grasping forceps, single-use
A sterile, rigid manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed as a very long instrument with one sliding and one stationary rod whose distal ends are equipped with grasping tongs or claws which are operated by scissors-like ring handles at the proximal end of the instrument. It is typically made of metal and plastic materials and is introduced into the body through the working channel of the endoscope to grasp internal structures for observation, excision, and/or biopsy procedures. This is a single-use device.
Obsolete false
58039 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 requires a patient contact return electrode to complete the circuit. It is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and may be designed to also mechanically cut tissues. This is a single-use device.
Active false
47342 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.
Obsolete false
42412 Laparoscopic access cannula, single-use
A 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 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 additionally be intended for thoracoscopy whereby the valve may not be required. 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. This is a single-use device.
Active false
12750 Spring-loaded pneumoperitoneum needle, single-use
A slender, sharply-pointed metal tube designed to introduce or remove gas from the peritoneal cavity as a therapeutic or surgical/radiological procedural method. It is often inserted into the peritoneal cavity for the purpose of insufflation [e.g., with carbon dioxide (CO2)] to establish pneumoperitoneum prior to abdominal endoscopy. It is equipped with a spring-loaded, round-tipped obturator that extends from the tube when the device does not encounter resistance (i.e., when the cavity has been reached) to prevent damage from the sharp point. This is a single-use device.
Active false
35649 Ligation clip, metallic
A 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; a dedicated, disposable clip applier may be included.
Active true
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FDA Product Code

[?]
Product Code Product Code Name
NWV Laparoscopic Accessories, Gynecologic
FHF System, Evacuator, Fluid
HET Laparoscope, Gynecologic (And Accessories)
GCJ Laparoscope, General & Plastic Surgery
FZP Clip, Implantable
MDM Instrument, Manual, Surgical, General Use
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

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

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

7e28a2fe-6d46-4948-b25f-e213a616ba56
February 05, 2021
5
October 09, 2015
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

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

[?]
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

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
1.949.713.8300
contact@appliedmedical.com
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