AM CHOLE KIT-TAM1

DI: 30607915121885 · Model: K0509 · APPLIED MEDICAL RESOURCES CORPORATION

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: AM CHOLE KIT-TAM1
Primary DI: 30607915121885
Version / Model: K0509
Company Name: APPLIED MEDICAL RESOURCES CORPORATION
Labeler DUNS: 187129135
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2015-10-16
Public Version: 5
Public Version Date: 2021-02-05
Public Version Status: Update
Public Device Record Key: 3064b3aa-793d-4357-82e2-2706f45c8ad4

Device Description

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CB010, 5MMx34CM SCISSOR REPOS CRTR 10/BX C0R85, 12x100MM Kii® BLT TIP SYS 6/BX CTB33, 11X100 Kii® SH BLD ZTHR 6/BX CTB03, 5x100 Kii® SH BLD ZTHR 6/BX

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HET	Laparoscope, Gynecologic (And Accessories)	Obstetrics/Gynecology	884.1720	2
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	876.1500	2
FZP	Clip, Implantable	General, Plastic Surgery	878.4300	2
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	878.4800	1

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active
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.	No	Active
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.	Yes	Active