FDA.reportPublic FDA data

ACUCISE® PROCEDURAL PACK FEMALE PACK B

Primary DI
20607915128191
Brand
ACUCISE® PROCEDURAL PACK FEMALE PACK B
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
BK024
Device description
Kit Contains: B1005, ACUCISE® ENDOPYELOTOMY SYSTEM B3301, STENT, C-FLEX, 7/10F X 26CM B7076, FORTE AxP SET 12/14/18F 28CM 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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNYAccessories, Catheter, G-U

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNYAccessories, Catheter, G-UGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20607915128191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2060791512819120607915128191

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607915146467Voyant Electrosurgical GeneratorEA0302026-01-16
00607915149024Inzii Ripstop Retrieval SystemCD0082026-01-16
00607915140700Alexis® Orthopaedic ProtectorHR1002024-07-11
00607915114688Threaded Cannula and SealC05682016-09-24
10607915140325Alexis® O Wound Protector-RetractorC84062022-05-27
10607915145528Inzii Ripstop Redeployable Retrieval SystemCD0052024-03-19
00607915146498Suction Irrigation SystemC60012024-02-01
00607915146504Suction Irrigation SystemC60032024-02-01
10607915140790Voyant Maryland Fusion Device with Single-Step ActivationEB2122022-12-13
00607915140809Voyant Maryland Fusion Device with Single-Step ActivationEB2132022-12-13
10607915140813Voyant Maryland Fusion Device with Single-Step ActivationEB2142022-12-13
10607915145313GelPOINT V-Path C2B112023-03-17
10607915145320GelPOINT V-Path C2B122023-03-17
10607915145337GelPOINT V-Path C2B152023-03-17
10607915145344GelPOINT V-Path C2C112023-03-17
10607915145351GelPOINT V-Path C2C122023-03-17
10607915145368GelPOINT V-Path C2C152023-03-17
10607915146693GelPOINT V-Path C2B172023-03-17
00607915145613GelPOINT V-Path C2A172023-02-17
10607915141797Alexis® Contained Extraction SystemGTB142022-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
50192253027646DoverCardinal Health 200, LLCKNY2024-07-10
10192253032338DoverCardinal Health 200, LLCKNY2024-07-10
03700512986195Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10 Fr x 35cmPromeplaKNY2017-11-09
03700512986201Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 35cmPromeplaKNY2017-11-09
03700512986218Ureteral Access Sheath with 2, 3 Fr working channels dilator, 10Frx45cmPromeplaKNY2017-11-09
03700512986225Ureteral Access Sheath with 2, 3 Fr working channels dilator, 12 Fr x 45cmPromeplaKNY2017-11-09
00821925027589VARI-PASS 10/12 Fr (3.3/4mm) x 54CMGyrus Acmi, Inc.KNY2017-05-11
10680651445787HalyardAvanos Medical, Inc.KNY2017-05-10
00821925005976UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005983UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
00821925005990UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-12
03700512983590BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 35cmPromeplaKNY2016-10-03
03700512983606BI-FLEX ACCESS SHEATH - 10 inner / 12 outer - Length 45cmPromeplaKNY2016-10-03
03700512983613BI-FLEX ACCESS SHEATH - 12 inner / 14 outer - Length 45cmPromeplaKNY2016-10-03
00821925035157UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035164UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035171UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035188UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035195UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035201UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035218UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035225UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035256UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035270UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035287UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035294UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
00821925035300UroPass Ureteral Access SheathGyrus Acmi, Inc.KNY2016-10-03
20884521007816DoverCardinal Health, Inc.KNY2016-09-24
10607915111660Acucise® Endopyelotomy SystemAPPLIED MEDICAL RESOURCES CORPORATIONKNY2016-09-24
04048551086025n.a.Karl Storz GmbH & Co. KGKNY2016-09-23