FDA.reportPublic FDA data

Stylet

Primary DI
10607915111196
Brand
Stylet
Company
APPLIED MEDICAL RESOURCES CORPORATION
Model
A4S140
Device description
Catheter Stylet
Published
2016-08-19
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
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10607915111196PackageGS110Not in Commercial Distribution
00607915111199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060791511119610607915111196
00607915111199006079151111996079151111990607915111199

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter styletA thin sterile wire intended to be inserted within the lumen of a vascular catheter [e.g., peripheraly inserted venous catheter (PICC)] to stiffen and/or maintain the shape of the catheter to facilitate insertion; it is not intended for introduction into the coronary vasculature. It may be magnetic to enable use with a magnetic tracking system. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length40Centimeter

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
false
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
false
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
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeINARI MEDICAL INCDXE2024-12-20
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194071ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194088ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194095ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194101ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902196617ARROWTELEFLEX INCORPORATEDDXE2022-11-08
00815948023802Indigo SystemPENUMBRA, INC.DXE2022-09-01
00815948023857Indigo SystemPENUMBRA, INC.DXE2022-09-01
00815948024281IndigoPENUMBRA, INC.DXE2022-03-04
00815948024335Indigo SystemPENUMBRA, INC.DXE2022-03-04
00815948024342Indigo SystemPENUMBRA, INC.DXE2022-03-04
00840663109616Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109623Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109630Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109647Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109654Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109661Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109678Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18
00840663109685Syntel Silicone Embolectomy CatheterLemaitre Vascular, Inc.DXE2021-06-18