FDA.reportPublic FDA data

ACUCISE® PROCEDURAL PACK STARTER PACK

Primary DI
20607915125947
Brand
ACUCISE® PROCEDURAL PACK STARTER PACK
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
BK001
Device description
Kit Contains:B1005, ACUCISE® ENDOPYELOTOMY SYSTEMB1201, URO TAMPONADE BALLOON CATHB3304, STENT, C-FLEX 7/10F x 24 CMB3301, STENT, C-FLEX, 7/10F X 26CMB3302, STENT, C-FLEX, 7/10F X 28CMB3303, STENT, C-FLEX, 7/10F X 30CMB7016, FORTE AxP SET 12/14/18F 35CM 6/BX
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
KNYAccessories, Catheter, G-U

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
KNYAccessories, Catheter, G-UGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607915125947PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2060791512594720607915125947

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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00607915110123Epix Laparoscopic ScissorsCB0302016-09-24
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
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00607915110147Epix Laparoscopic GrasperC41302016-08-30
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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
00607915117382Inzii Retrieval SystemCD0012016-09-24
00607915123406Inzii Retrieval SystemCD0032016-09-24
00607915128760Epix® Reusable ProbeC72022016-08-19
00607915128777Epix® Reusable ProbeC72112016-08-19
00607915128784Epix® Reusable ProbeC72042016-08-19
00607915128791Epix® Reusable ProbeC72052016-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936345101536Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345101543Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104469Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104476Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104483Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104490Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104544Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104551Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104568Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
06936345104575Disposable Ureteral Guide SheathDongguan ZSR Biomedical Technology Company LimitedFED2026-05-27
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08714729056676PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
08714729057093PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
08714729077046PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
08714729077053PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
08714729077060PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
08714729077077PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
08714729077084PTFE Coated Urological GuidewireLAKE REGION MEDICAL LIMITEDEZB2016-11-10
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08714729161691OccluderBOSTON SCIENTIFIC CORPORATIONEYB2016-09-24
08714729191988OccluderBOSTON SCIENTIFIC CORPORATIONEYB2016-09-24
08714729191995OccluderBOSTON SCIENTIFIC CORPORATIONEYB2016-09-24
08714729192008OccluderBOSTON SCIENTIFIC CORPORATIONEYB2016-09-24
08714729376354SensorBOSTON SCIENTIFIC CORPORATIONEZB2016-09-24
08714729376361SensorBOSTON SCIENTIFIC CORPORATIONEZB2016-09-24