FDA.reportPublic FDA data

PICOCLAMP

Primary DI
04946585324109
Brand
PICOCLAMP
Company
KONO SEISAKUSHO CO.,LTD.
Model
PAS-D
Catalog number
PAS-D
Published
2023-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K230281000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230281000PICOCLAMPKono Seisakusho Co., Ltd.2023-10-23DXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14946585324106PackageGS112In Commercial Distribution
04946585324109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1494658532410614946585324106
04946585324109049465853241094946585324109

GMDN Terms#

Term, Definition table
TermDefinition
Surgical bulldog clamp, single-useA manual surgical instrument designed to grasp, join, compress or support an organ, vessel or soft-tissue. It has a flat, pincer-like design with self-retaining jaws that open upon squeezing of the handles and close upon release; it is typically made of plastic. It is commonly used for vascular clamping and is not dedicated to a specific type of non-vascular surgery. This is a single-use device.

Regulatory Flags#

DUNS number
691486468
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04946585362286CROWNJUN Nylon SutureMS-0082026-03-12
04946585362293CROWNJUN Nylon SutureMS-0182026-03-12
04946585362309CROWNJUN Nylon SutureMS-0092026-03-12
04946585362316CROWNJUN Nylon SutureMS-0192026-03-12
04946585362323CROWNJUN Nylon SutureMS-00V2026-03-12
04946585362330CROWNJUN Nylon SutureMS-01V2026-03-12
04946585362347CROWNJUN Nylon SutureMS-00W2026-03-12
04946585362354CROWNJUN Nylon SutureMS-01W2026-03-12
04946585362361CROWNJUN Nylon SutureMS-00X2026-03-12
04946585362378CROWNJUN Nylon SutureMS-01X2026-03-12
04946585362385CROWNJUN Nylon SutureMS-02X2026-03-12
04946585362392CROWNJUN Nylon SutureMS-03X2026-03-12
04946585362408CROWNJUN Nylon SutureMS-00Y2026-03-12
04946585362415CROWNJUN Nylon SutureMS-01Y2026-03-12
14946585362283CROWNJUN Nylon SutureMS-0082026-03-12
14946585362290CROWNJUN Nylon SutureMS-0182026-03-12
14946585362306CROWNJUN Nylon SutureMS-0092026-03-12
14946585362313CROWNJUN Nylon SutureMS-0192026-03-12
14946585362320CROWNJUN Nylon SutureMS-00V2026-03-12
14946585362337CROWNJUN Nylon SutureMS-01V2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30
00190776404178MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776404185MillenniumAvalign Technologies, Inc.DXC2026-07-24
00190776400248MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403287MillenniumAvalign Technologies, Inc.DXC2026-07-21
00190776403294MillenniumAvalign Technologies, Inc.DXC2026-07-21
00810220800461Adler Instrument CompanyAdler, Inc.DXC2026-07-17
00190776397180MillenniumAvalign Technologies, Inc.DXC2026-07-16
00190776395605MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395698MillenniumAvalign Technologies, Inc.DXC2026-07-14
00190776395711MillenniumAvalign Technologies, Inc.DXC2026-07-14
00192896123557Debakey Neonatal ClampSONTEC INSTRUMENTS, INC.DXC2026-07-10
00846159036152SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-23
00846159036404SCANLAN® Bulldog ClampSCANLAN INTERNATIONAL INCDXC2026-06-09
00810220800348Adler Instrument CompanyAdler, Inc.DXC2026-06-02
10197344138890NAMICMEDLINE INDUSTRIES, INC.DXC2026-03-16
08022057015884DeTACH Aortic Cross Clamp Head-LargeCORCYM SRLDXC2026-02-03
08022057015907DeTACH Aortic Cross Clamp Head-SmallCORCYM SRLDXC2026-02-03
10193489727173Medline Industries, Inc.MEDLINE INDUSTRIES, INC.DXC2022-08-04
10195594150808CARDINAL HEALTHCardinal Health 200, LLCDXC2021-07-09
00822045000391SAM® Junctional TourniquetSAM Medical ProductsDXC2020-04-01
20884521152134CovidienCardinal Health, Inc.DXC2016-09-24
M20630300D-Stat® Clamp topical hemostat accessoryVascular Solutions, Inc.DXC2016-09-15
M20635240Vasc Band™ hemostatVascular Solutions, Inc.DXC2016-09-05