FDA.reportPublic FDA data

SJM™

Primary DI
15414734053850
Brand
SJM™
Company
ST. JUDE MEDICAL, INC.
Model
406998
Catalog number
406998
Published
2016-01-22
Public version status
Update
Distribution status
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
DYBINTRODUCER, CATHETER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15414734053850PackageGS110In Commercial Distribution
05414734053853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1541473405385015414734053850
05414734053853054147340538535414734053853

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-use, sterileA sterile device designed to be applied to a variety of surgical or invasive instruments to protect the instrument and/or its operator and/or the patient from injury, distortion, or damage during a procedure, handling, and/or storage. It is typically made of stainless steel or plastic materials. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DARK, DRY PLACE.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(855)478-5833customerservice@sjm.com

Regulatory Flags#

DUNS number
149818952
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
true
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
05414734509138NA3630W3630W2026-03-04
05415067056009Volt™K-VOLT-HDI-MK-VOLT-HDI-M2026-02-25
05415067056016Volt™K-VOLT-HDI-SK-VOLT-HDI-S2026-02-25
05415067056023Volt™K-VOLT-I-MK-VOLT-I-M2026-02-25
05415067056030Volt™K-VOLT-I-SK-VOLT-I-S2026-02-25
05415067055507Zenex MRI™PM1283PM12832026-01-22
05415067055514Zenex MRI™PM2283PM22832026-01-22
05415067036650Navitor™NVTR-LS-LGNVTR-LS-LG2023-01-16
05415067036667Navitor™NVTR-LS-SMNVTR-LS-SM2023-01-16
05415067055613EnSite™ENSITE-SW-06ENSITE-SW-062026-01-08
05415067051417Current™PFA-ECG-LNAMPFA-ECG-LNAM2026-01-06
05415067051516Current™PFA-GEN-01PFA-GEN-012026-01-06
05415067051554Current™PFA-ECG-CBLPFA-ECG-CBL2026-01-06
05415067051615Current™PFA-ECG-RNAMPFA-ECG-RNAM2026-01-06
05415067051721Current™PFA-GEN-CARTPFA-GEN-CART2026-01-06
05415067051752Current™PFA-R-GEN-01PFA-R-GEN-012026-01-06
05415067051813Current™GEN-3RD-RECGEN-3RD-REC2026-01-06
05415067052919Current™PFA-CIM-CBLPFA-CIM-CBL2026-01-06
05415067053022Volt™ PFA Sensor Enabled™A-VOLT-01A-VOLT-012026-01-06
05415067053886Current™PFA-GEN-V101PFA-GEN-V1012026-01-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00849884007541VYGONVygon CorporationDYB2026-05-22
00849884007558VYGONVygon CorporationDYB2026-05-22
20886333227864V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227871V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227888V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227895V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227901V-Stick Vascular Access Set ARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227918V- Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227925V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
20886333227932V-Stick Vascular Access SetARGON MEDICAL DEVICES, INC.DYB2026-03-20
00813502010411Impella RP Flex Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011685Abiomed Impella CP 14Fr Introducer KitAbiomed, Inc.DYB2026-03-11
00813502011692Abiomed Impella CP 14Fr Introducer Kit Abiomed, Inc.DYB2026-03-11
20801902225508ARROWTELEFLEX INCORPORATEDDYB2026-03-11
20801902225546ARROWTELEFLEX INCORPORATEDDYB2026-03-11
00840479401263enableCV Introducer SheathENABLECV INC.DYB2026-02-26
20884450113992Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
20884450115804Prelude IDeal™Merit Medical Systems, Inc.DYB2026-02-25
00884450489642Prelude SNAP™Merit Medical Systems, Inc.DYB2026-02-21
30884908188456MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
30884908188463MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188474MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
50884908188481MICRO-STICK SETMedical Components, Inc.DYB2026-02-19
20801902225362ARROWTELEFLEX INCORPORATEDDYB2026-02-17
20884450119475Prelude EASE™Merit Medical Systems, Inc.DYB2026-02-14
50382903829120Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
30382903829249Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829472Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
50382903829540Insyte AutoguardBECTON, DICKINSON AND COMPANYDYB2026-02-13
20801902225133ARROWTELEFLEX INCORPORATEDDYB2026-02-13