DEVICE: DR. FARROW-LEE KATY SC (30607915135967)
Device Identifier (DI) Information
DR. FARROW-LEE KATY SC
K2837
In Commercial Distribution
APPLIED MEDICAL RESOURCES CORPORATION
K2837
In Commercial Distribution
APPLIED MEDICAL RESOURCES CORPORATION
Kit Contains:
CA500, EPIX® UNIVERSAL CLIP APPLIER 3/BX
CTF33, 11x100 Kii® Fios® ZTHR 6/BX
CTF03, 5x100 Kii® Fios® Z-THR 6/BX
CTS02, 5x100 Kii® SLEEVE ZTHR 12/BX
C7100, EPIX® SI CARTRIDGE SET, 12/BX
C4130, 5mmx35cm EPIX® LAPA GRASPER, 10/BX
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. 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 |
47625 | Surgical irrigation/aspiration tubing set |
A collection of flexible, noninvasive, double-lumen tubing and associated items intended to provide twin conduits in a surgical irrigation/aspiration system to deliver irrigation solution (e.g., saline) from its source (e.g., gravity feed bag) to a surgical cannula (not included) through one lumen, and provide aspiration (suction) through the other lumen (i.e., enables both irrigation and aspiration), during a surgical procedure (e.g., dental, laparoscopy). The tubing set includes devices such as clamps, filters, spikes, and Y-piece connectors, and may in addition include an integrated manual pump (e.g., a squeeze bulb) or handpiece. This is a single-use device.
|
Active | 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 |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NWV | Laparoscopic Accessories, Gynecologic |
BTA | Pump, Portable, Aspiration (Manual Or Powered) |
GCJ | Laparoscope, General & Plastic Surgery |
FZP | Clip, Implantable |
MDM | Instrument, Manual, Surgical, General Use |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3601eecf-99ef-4eb7-baa8-b869174cf9ab
February 05, 2021
6
October 27, 2015
February 05, 2021
6
October 27, 2015
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
1.949.713.8300
contact@appliedmedical.com
contact@appliedmedical.com