FDA.reportPublic FDA data

PICOCLAMP

Primary DI
04946585324185
Brand
PICOCLAMP
Company
KONO SEISAKUSHO CO.,LTD.
Model
PAL-D
Catalog number
PAL-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
14946585324182PackageGS112In Commercial Distribution
04946585324185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1494658532418214946585324182
04946585324185049465853241854946585324185

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
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
00885403523277FOGARTY SOFTJAWBecton, Dickinson And CompanyDXC2026-07-30
10841156102012D-STATTELEFLEX INCORPORATEDDXC2026-07-30