FDA.reportPublic FDA data

CardioCel Neo Bioscaffold Patch 5 cm X 8 cm

Primary DI
00840663110773
Brand
CardioCel Neo Bioscaffold Patch 5 cm X 8 cm
Company
Lemaitre Vascular, Inc.
Model
UC0508N
Published
2024-10-10
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
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130872000CARDIOCELCelxcel Pty, Ltd.2014-01-30DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663110773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663110773008406631107738406631107730840663110773

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedAn implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184805166
Device count
1
HCT/P
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663102297Eze-Sit Valvulotome94cmTIVK20302022-06-30
00840663100095Expandable LeMaitre Valvulotome1000-901000-902015-06-30
00840663100101Expandable LeMaitre Valvulotomee1000-90e1000-902015-06-30
00840663100118Expandable LeMaitre Valvulotome1000-951000-952015-06-30
00840663100132Over-the-Wire LeMaitre Valvulotome1005-001005-002015-06-30
00840663100149Over-the-Wire LeMaitre Valvulotomee1005-00e1005-002015-06-30
00840663100163Over-the-Wire LeMaitre Valvulotome1006-001006-002015-06-30
00840663100309Expandable LeMaitre Valvulotome1096-001096-002015-06-30
00840663106653HYDRO LeMaitre Valvulotome1009-001009-002015-06-30
00840663106660HYDRO LeMaitre Valvulotome1010-001010-002015-06-30
00840663106721Expandable LeMaitre Valvulotomee1096-00e1096-002015-07-15
00840663106820Hydro LeMaitre Valvulotomee1009-00e1009-002015-07-15
00840663106837Hydro LeMaitre Valvulotomee1010-00e1010-002015-07-15
00840663107315Retrograde LeMills Valvulotome1050-001050-002015-06-30
00840663107322Antegrade LeMills Valvulotome1050-011050-012015-06-30
00840663107339Antegrade and Retrograde LeMills Valvulotome1050-021050-022015-06-30
00840663107346Retrograde LeMills Valvulotomee1050-00e1050-002015-06-30
00840663107353Antegrade LeMills Valvulotomee1050-01e1050-012015-06-30
00840663107360Antegrade and Retrograde LeMills Valvulotomee1050-02e1050-022015-06-30
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
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14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
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14026704646781DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646798DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646804DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462229ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462335ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462359ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
00859389005102Tyke, Patch, Pledget and IntracardiacElutia Med LLCDXZ2019-02-28
14026704638540DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638557DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
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14026704638588DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638601DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638618DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638625DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638632DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638649DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638656DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638663DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
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