ADV FIXATION SURGICAL KIT

DI: 30607915135905 · Model: K0903 · APPLIED MEDICAL RESOURCES CORPORATION

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Product Codes

GMDN Terms

Identifiers

Pkg Device Count

Basic Information

Brand Name: ADV FIXATION SURGICAL KIT
Primary DI: 30607915135905
Version / Model: K0903
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: 4
Public Version Date: 2021-02-05
Public Version Status: Update
Public Device Record Key: d5e40637-8687-4ebb-8b26-e694e4df808d

Device Description

Kit Contains: CA090, DIRECT DRIVE® LCA 3/BX CFR03, 5X100 Kii® OPT ADVFIX 6/BX CFS02, 5x100 Kii® SLEEVE ADVFIX 12/BX CFR73, 12x100 Kii® OPT ADVFIX 6/BX CFS22, 12x100 Kii® SLEEVE ADVFIX 12/BX C2201, 120MM INSUFF NEEDLE XE, 20/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
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.	No	Active
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
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