ACUCISE® PROCEDURAL PACK

Basic Information

• Brand Name: ACUCISE® PROCEDURAL PACK
• Primary DI: 20607915128177
• Version / Model: BK022
• Company Name: APPLIED MEDICAL RESOURCES CORPORATION
• Labeler DUNS: 187129135
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-09
• Public Version: 4
• Public Version Date: 2019-02-08
• Public Version Status: Update
• Public Device Record Key: 54ec5614-4a20-4857-954a-827dc1215b55
• Distribution End Date: 2018-10-28

Device Description

Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B7016, FORTE AxP SET 12/14/18F 35CM 6/BX B3305, STENT, C-FLEX 7/10F x 22 CM

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
FAD	Stent, Ureteral	Gastroenterology, Urology	876.4620	2
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	876.1500	2
KNY	Accessories, Catheter, G-U	Gastroenterology, Urology	876.5130	2
EZB	Stylet For Catheter, Gastro-Urology	Gastroenterology, Urology	876.5130	1
DXT	Injector And Syringe, Angiographic	Cardiovascular	870.1650	2
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	876.5130	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
47053	Ureteral stent-placement set	A collection of devices used to facilitate the implantation of a ureteral stent, via the natural orifice or percutaneously through a tortuous ureter, in order to maintain ureteral patency. The devices are typically made of high-grade stainless steel and/or a polymer [e.g., polyvinyl chloride (PVC)] and typically include a guidewire, a dilator, a positioner, an inserter, a placement catheter, an introduction sheath, and a release sleeve. Some of the devices may be radiopaque, and may have Luer connectors at the proximal end to allow for the injection of a contrast medium. This is a single-use device.	No	Active
58005	Polymeric ureteral stent	A sterile non-bioabsorbable tubular device intended to be implanted in an obstructed ureter (e.g., from stone, stricture, compression, fibrosis, trauma) to maintain luminal patency allowing urine to drain from the renal pelvis to the bladder. It is made of a synthetic polymer(s) [e.g., polytetrafluoroethylene (PTFE), polyethylene (PE), silicone], sometimes with a hydrophilic coating (e.g., hydrogel), and may have various designs (e.g., continuous tube with or without drainage side holes, covered or non-covered mesh structure). Disposable devices intended to assist implantation may be included. The device is typically intended for long-term, but not permanent, implantation.	Yes	Active
34926	Ureteral catheter	A flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.	No	Active
46691	Gastro-urological guidewire, single-use	A sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	20607915128177	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]