FDA.report

FOGARTY HYDRAJAW

Primary DI
00690103044249
Brand
FOGARTY HYDRAJAW
Company
Edwards Lifesciences LLC
Model
DHYDRA86
Catalog number
DHYDRA86
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
00690103044249PrimaryGS10
70690103044248Unit 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

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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
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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

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00192896121638Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2025-06-17
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