FDA.reportPublic FDA data

SureCUT

Primary DI
M95550010
Brand
SureCUT
Company
SENTREHEART, INC
Model
5001
Catalog number
5001
Device description
A sterile, hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.
Published
2018-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCutter, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M95550010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Suture cutter, single-useA hand-held surgical instrument designed for cutting sutures using a mechanical action. It typically has a protected scalpel-like blade or a scissors-like cutting end, and a proximal manual actuator. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
650-354-1200info@sentreheart.com

Regulatory Flags#

DUNS number
068810802
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M95520060EndoCATH200620062016-09-23
M95580020Tensure7 lb80022018-09-17
M95560020SofTIPLong60022018-09-17
M95530050LariatIII30052016-09-23
M95530060LariatRS2016-10-14
M95540050FindrWIRZ400540052016-09-23

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