FDA.report

CHOLE KIT 9

Primary DI
20607915134116
Brand
CHOLE KIT 9
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
GK416
Device description
Kit Contains: CD003, 5mm RETRIEVAL SYSTEM, 10/BX CA500, EPIX UNIVERSALERSAL CLIP APPLIER 3/BX CB030, 5mmx35cm EPIX LAPA SCISSOR, 10/BX C6001, 5mmX33cm PROB/VALV DUAL BAG 12/BX CFF03, 5x100 Kii Fios ADVFIX 6/BX CTS02, 5x100 Kii SLEEVE ZTHR 12/BX CTF33, 11x100 Kii Fios ZTHR 6/BX
Published
2015-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
FHFSystem, Evacuator, Fluid

Product Code Classifications

CodeDeviceSpecialtyClass
FHFSystem, Evacuator, FluidGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20607915134116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2060791513411620607915134116

GMDN Terms

TermDefinition
Laparoscopic access cannula, single-useA 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.

Sterilization Methods

Method

Contacts

PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags

DUNS number
187129135
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00860009877818ClearwandMORRIS MEDICAL, INC.FHF2024-10-22
00607915146498Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
00607915146504Suction Irrigation SystemAPPLIED MEDICAL RESOURCES CORPORATIONFHF2024-02-01
03700512912101RocaFlow Endoscopy TubingPromeplaFHF2020-08-27
03700512922032Urology Trawer Flow 1 SpikePromeplaFHF2019-10-21
03700512922049Urology TURP Post-Op 2 SpikePromeplaFHF2019-10-21
03700512922056Urology TURP 2 SpikePromeplaFHF2019-10-21
03700512922063Urology Traxer Flow 2 spikesPromeplaFHF2019-10-21
03700512922070Urology Diagnostic TURP 2 SpikePromeplaFHF2019-10-21
03700512922087Urology TURP Post-Op Extra SpikePromeplaFHF2019-10-21
03700512921974Laparoscopy Set for ROCAFLOW - 2 ways PromeplaFHF2018-08-03
26939029815181SEEMANNModern Medical Equipment MFG. Ltd.FHF2017-12-27
26939029815167MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
26939029815174MEDLINEModern Medical Equipment MFG. Ltd.FHF2017-12-16
03700512921837Irrigation/Aspiration set for TURP (Urology) - 2 spikes - pump segmentPromeplaFHF2017-11-13
03700512921868Irrigation/Aspiration set for TURP/Post-operative irrigation (Urology)PromeplaFHF2017-11-13
03700512921813Traxer Flow Dual Port- Irrigation set for Laser Ureteroscopy - 1 spikePromeplaFHF2017-11-09
03700512921844Traxer Flow Dual Port - Irrigation set for Laser Ureteroscopy - 2 spikes PromeplaFHF2017-11-09
03700512921141Urology - TRAXERFLOW -2 Way Irrigation set Ureteroscopy with laserPromeplaFHF2016-11-24
03700512921653Urology - TRAXERFLOW -2 Way Irrigation set Ureteroscopy with laserPromeplaFHF2016-11-24
03700512921110Urology - TRAXERFLOW PromeplaFHF2016-10-25
03700512911029Laparoscopy - 1 Way Irrigation/Aspiration set (without handpiece & probe)PromeplaFHF2016-10-11
03700512911036Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip, PromeplaFHF2016-10-11
03700512921042Laparoscopy - 1 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip)PromeplaFHF2016-10-11
03700512921059Laparoscopy - 2 Way Irrigation/Aspiration set + Handpiece (for Æ 5mm probe tip)PromeplaFHF2016-10-11
03700512911067Laparoscopy - 1 Way High Flow Irrigation/Aspiration set + Handpiece & probe (Æ PromeplaFHF2016-10-11
03700512921073Gynecology - 1 way Hysterescopy setPromeplaFHF2016-10-11
03700512921080Gynecology - 1 way Hysteroscopy set with aspiration tubingPromeplaFHF2016-10-11
03700512921097Gynecology - 2 way Hysterescopy setPromeplaFHF2016-10-11
03700512921103Gynecology - 2 way Hysteroscopy set 2 spike with aspiration tubingPromeplaFHF2016-10-11