FDA.reportPublic FDA data

ACUCISE® PROCEDURAL PACK

Primary DI
20607915128177
Brand
ACUCISE® PROCEDURAL PACK
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
BK022
Device description
Kit Contains:B1005, ACUCISE® ENDOPYELOTOMY SYSTEMB7016, FORTE AxP SET 12/14/18F 35CM 6/BXB3305, STENT, C-FLEX 7/10F x 22 CM
Published
2015-10-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DXTInjector And Syringe, Angiographic
EYBCatheter, Ureteral, Gastro-Urology
EZBStylet For Catheter, Gastro-Urology
FADStent, Ureteral
FEDEndoscopic Access Overtube, Gastroenterology-Urology
FZPClip, Implantable
KNYAccessories, Catheter, G-U
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXTInjector And Syringe, AngiographicCardiovascular2
EYBCatheter, Ureteral, Gastro-UrologyGastroenterology, Urology2
EZBStylet For Catheter, Gastro-UrologyGastroenterology, Urology1
FADStent, UreteralGastroenterology, Urology2
FEDEndoscopic Access Overtube, Gastroenterology-UrologyGastroenterology, Urology2
FZPClip, ImplantableGeneral, Plastic Surgery2
KNYAccessories, Catheter, G-UGastroenterology, Urology2
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607915128177PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2060791512817720607915128177

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral stent-placement setA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1.949.713.8300contact@appliedmedical.com

Regulatory Flags#

DUNS number
187129135
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
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10607915145313GelPOINT V-PathC2B112023-03-17
10607915145320GelPOINT V-PathC2B122023-03-17
10607915145337GelPOINT V-PathC2B152023-03-17
10607915145344GelPOINT V-PathC2C112023-03-17
10607915145368GelPOINT V-PathC2C152023-03-17
10607915146693GelPOINT V-PathC2B172023-03-17
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00607915110130Epix Laparoscopic ScissorsCB0402016-09-24
00607915142087Alexis® Lighted Wound Protector-RetractorCL4022026-04-22
00607915148553Alexis® Lighted Wound Protector-RetractorCL3022026-04-22
10607915147812GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceC2R122026-04-22
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
00607915110147Epix Laparoscopic GrasperC41302016-08-30
00607915110154Epix Laparoscopic GrasperC41402016-08-30
00607915116866Direct Drive Reposable GraspersC41202016-08-30
00607915116873Direct Drive Reposable GraspersC41212016-08-30
00607915126773Inzii Retrieval SystemCD0042016-09-24
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915126964Epix ® Laparoscopic Dissector CY0102016-09-24

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