BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

FOGARTY SAFEJAW-HYDRAJAW

DI: 00690103045697 · Model: SAFEHY33 · Edwards Lifesciences LLC

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

10

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Basic Information

Brand Name: FOGARTY SAFEJAW-HYDRAJAW
Primary DI: 00690103045697
Version / Model: SAFEHY33
Catalog Number: SAFEHY33
Company Name: Edwards Lifesciences LLC
Labeler DUNS: 134139174
Distribution Status: In Commercial Distribution
Device Count in Pkg: 10
Record Status: Published
Publish Date: 2016-09-03
Public Version: 2
Public Version Date: 2018-03-29
Public Version Status: Update
Public Device Record Key: 71710d32-2bca-4efa-bf61-1153620ec4f2

Device Description

FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: Yes
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: Yes
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
DXC	CLAMP, VASCULAR	Cardiovascular	870.4450	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47068	Vascular clamp, single-use	A 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.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00690103045697	GS1
Unit of Use	70690103045696	GS1

Customer Contacts

Phone: +1(800)822-9637
Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			USABLE LENGTH: 33MM

Storage Conditions

Type: Special Storage Condition, Specify
Special Conditions: STORE IN A COOL, DRY PLACE.