FDA.reportPublic FDA data

FOGARTY SOFTJAW

Primary DI
00885403523277
Brand
FOGARTY SOFTJAW
Company
Becton, Dickinson And Company
Model
SOFT86
Catalog number
SOFT86
Device description
FOGARTY - HYDRAGRIP SURGICAL - CLAMP INSERTS
Published
2026-07-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXCCLAMP, VASCULAR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXCClamp, VascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260105000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260105000Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsEdwards Lifesciences2026-06-05DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103045741PreviousGS10
00885403523277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103045741006901030457416901030457410690103045741
00885403523277008854035232778854035232770885403523277

GMDN Terms#

Term, Definition table
TermDefinition
Coronary artery clampA hand-held, manual surgical instrument designed to directly compress a coronary artery during coronary artery graft surgery to create a temporary atraumatic haemostasis (arrest or prevention of bleeding). It may be referred to as a clip or a clamp, is made of plastic, and has a self-retaining design; it is not in the form of a bulldog clamp nor scissors-like forceps. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Conditions (see IFU)
Special Storage Condition, Specify00Store in a cool, dry place

Regulatory Flags#

DUNS number
145014099
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00382904411268BD ProbeTec™ Chlamydia trachomatis (CT) Qx Amplified DNA Assay4411264411262018-05-25
00885403523437HemoSphere AltaALTAALL1ALTAALL12026-08-06
00885403523451HemoSphere AltaALTASR1ALTASR12026-08-06
00885403523475HemoSphere AltaALTACR1ALTACR12026-08-06
00382906718167Horizon6718166718162026-09-24
00382906718174Horizon6718176718172026-09-24
00382906718181Horizon6718186718182026-09-24
00382906718198Horizon6718196718192026-09-24
00382906718204Horizon6718206718202026-09-24
00382906718211Horizon6718216718212026-09-24
00382906718235Horizon6718236718232026-09-24
00382906718242Horizon6718246718242026-09-24
00382906718259Horizon6718256718252026-09-24
00382906718266Horizon6718266718262026-09-24
00382906718273Horizon6718276718272026-09-24
00382906718280Horizon6718286718282026-09-24
00382906718310Horizon6718316718312026-09-24
00382906718327Horizon6718326718322026-09-24
00382906718334Horizon6718336718332026-09-24
00382906718341Horizon6718346718342026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776436636MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436643MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776436681MilleniumAvalign Technologies, Inc.DXC2026-10-20
00190776437763MillenniumAvalign Technologies, Inc.DXC2026-10-20
00190776435226MillenniumAvalign Technologies, Inc.DXC2026-10-19
00190776436230MillenniumAvalign Technologies, Inc.DXC2026-10-08
00190776436247MillenniumAvalign Technologies, Inc.DXC2026-10-08
M68931200070CrOCSafeguard US Operating, LLCDXC2026-10-08
00190776434267MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434335MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434366MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776434373MillenniumAvalign Technologies, Inc.DXC2026-10-06
00190776433314MillenniumAvalign Technologies, Inc.DXC2026-10-05
00810220800577Adler Instrument CompanyAdler, Inc.DXC2026-09-30
00846159036411SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00846159036428SCANLAN® ClampSCANLAN INTERNATIONAL INCDXC2026-09-21
00190776424107MillenniumAvalign Technologies, Inc.DXC2026-08-27
00190776423889MillenniumAvalign Technologies, Inc.DXC2026-08-26
00190776420345MillenniumAvalign Technologies, Inc.DXC2026-08-25
00190776419080MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776419127MillenniumAvalign Technologies, Inc.DXC2026-08-23
00190776417154MillenniumAvalign Technologies, Inc.DXC2026-08-19
00190776411527MillenniumAvalign Technologies, Inc.DXC2026-08-07
00190776408633MillenniumAvalign Technologies, Inc.DXC2026-08-03
00190776422318MillenniumAvalign Technologies, Inc.DXC2026-07-31
00885403523000FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523161FOGARTY HYDRAJAWBecton, Dickinson And CompanyDXC2026-07-30
00885403523253FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24