FDA.report

FOGARTY SAFEJAW

Primary DI
00690103045680
Brand
FOGARTY SAFEJAW
Company
Edwards Lifesciences LLC
Model
SAFE86
Catalog number
SAFE86
Device description
FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
Published
2016-09-03
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

Related Records

Product Codes

CodeName
DXCCLAMP, VASCULAR

Product Code Classifications

CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00690103045680PrimaryGS10
70690103045689Unit of UseGS10

GMDN Terms

TermDefinition
Vascular clamp, single-useA sterile, hand-held manual surgical instrument designed to directly compress a blood vessel (vein or artery) to create a temporary haemostasis (arrest or prevention of bleeding). It typically has a self-clamping, bulldog-like or scissors-like, ring-handled design with serrated jaws; the working end has blades of various designs (e.g., straight or angled). It is available in various sizes and is typically made of plastic materials. This is a single-use device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00STORE IN A COOL, DRY PLACE.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)822-9637tech_support@edwards.com

Regulatory Flags

DUNS number
134139174
Device count
10
DM exempt
false
Premarket exempt
true
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
57460691952770TRUWAVEPXMK1077PXMK10772026-03-20
57460691955887TRUWAVEPXMK1780PXMK17802026-03-20
00690103000382SWAN-GANZ TRUE SIZE123F6123F6P2026-03-16
50690103218287SWAN-GANZ VIP831F75831F75P2026-03-16
50690103218607SWAN-GANZ TRUE SIZE096F6096F6P2026-03-16
50690103218621SWAN-GANZ TRUE SIZE111F7111F7P2026-03-16
50690103218638SWAN-GANZ TRUE SIZE114F7114F7P2026-03-16
00690103221312Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL20A9631PL20A2026-02-17
00690103221329Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL23A9631PL23A2026-02-17
00690103221336Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL26A9631PL26A2026-02-17
00690103221343Edwards SAPIEN 3 transcatheter pulmonic valve delivery system9631PL29A9631PL29A2026-02-17
00690103019353AORTIC TRUE-SIZE OBTURATOR 19MM1161116119MM2026-02-13
00690103019360AORTIC TRUE-SIZE OBTURATOR 21MM1161116121MM2026-02-13
00690103019377AORTIC TRUE-SIZE OBTURATOR 23MM1161116123MM2026-02-13
00690103019384AORTIC TRUE-SIZE OBTURATOR 25MM1161116125MM2026-02-13
00690103019391AORTIC TRUE-SIZE OBTURATOR 27MM1161116127MM2026-02-13
00690103019407AORTIC TRUE-SIZE OBTURATOR 29MM1161116129MM2026-02-13
00690103019414AORTIC TRUE-SIZE OBTURATOR 31MM1161116131MM2026-02-13
00690103019278HEART VALVE SIZER ACCESSORY1127112723MM2026-02-11
00690103019285HEART VALVE SIZER ACCESSORY1127112725MM2026-02-11

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
20197344138897NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
00192896122697Cooley Vascular ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122710Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00192896122727Debakey Coarctation ClampSONTEC INSTRUMENTS, INC.DXC2026-03-10
00884450846032Safeguard Radial™Merit Medical Systems, Inc.DXC2026-02-20
00840479401027enableCV IntraClude™ Intra-Aortic Occlusion DeviceENABLECV INC.DXC2026-02-06
18022057015881DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015891DeTACH Aortic Cross Clamp Head- MediumCORCYM SRLDXC2026-02-03
18022057015904DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
08022057015914DeTACH Aortic Cross Clamp Delivery SystemCORCYM SRLDXC2026-02-03
08022057015921DeTACH Aortic Cross Clamp Quick Release DeviceCORCYM SRLDXC2026-02-03
08022057015945DeTACH Aortic Cross Clamp Delivery DeviceCORCYM SRLDXC2026-02-03
00810123209507Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209514Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209521Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209538Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209545Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209552Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209583Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209590Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209606Adler Instrument CompanyAdler, Inc.DXC2025-08-19
00810123209613Adler Instrument CompanyAdler, Inc.DXC2025-08-19
54026704930840PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930857PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930864PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930871PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930888PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
54026704930895PILLINGTELEFLEX INCORPORATEDDXC2025-07-21
00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
00192896121645Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17