FDA.reportPublic FDA data

DEKNATEL

Primary DI
24026704426441
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN026853
Catalog number
X-4420
Device description
PLED SOFT 1"X1"X1/16"
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
24026704426441PackageGS11In Commercial Distribution
44026704426445PackageGS112In Commercial Distribution
04026704426447PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2402670442644124026704426441
4402670442644544026704426445
04026704426447040267044264474026704426447

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, syntheticAn 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 non-bioabsorbable perforated patch made of synthetic polymer material [e.g., polypropylene, polytetrafluoroethylene (PTFE) or Teflon, felt], without biological materials, that is typically implanted with sutures. It is typically implanted during cardiovascular procedures but may also be used in other open and/or laparoscopic soft-tissue surgical procedures (e.g., hernia repair).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length75Centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(919)544-8000CS@TELEFLEX.COM

Regulatory Flags#

DUNS number
002348191
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
20801902219385ARROWEDC-00622EDC-006222026-03-24
30801902219405ARROWEDC-00820EDC-008202026-03-24
20801902219415ARROWEDC-00822EDC-008222026-03-24
20801902219460ARROWEDC-00818-MEDC-00818-M2026-03-24
20801902219484ARROWEDC-00622-HCEDC-00622-HC2026-03-24
20801902219514ARROWEDC-00822-HCEDC-00822-HC2026-03-24
20801902193418ARROWIPN920120AW-04432-N2026-03-23
30841156103983SUPERCROSS530253022026-03-23
20841156103993SUPERCROSS530353032026-03-23
20841156104006SUPERCROSS530453042026-03-23
20841156104013SUPERCROSS530553052026-03-23
20841156104020SUPERCROSS530653062026-03-23
20841156104037SUPERCROSS530753072026-03-23
20841156104044SUPERCROSS530853082026-03-23
30841156104058SUPERCROSS530953092026-03-23
24026704941494PILLINGP12797P127972026-03-23
24026704941500PILLINGP12805P128052026-03-23
24026704941555PILLINGP13063P130632026-03-23
24026704941562PILLINGP13065P130652026-03-23
24026704941579PILLINGP13081P130812026-03-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589795950241PeriBeam® Pericardial MembraneTAMABIO CO., LTD.DXZ2026-03-17
00840663110551CardioCel Bioscaffold Patch 4 cm X 4 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110568CardioCel Bioscaffold Patch 5 cm X 8 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110575CardioCel Bioscaffold Patch 6 cm X 14 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110605CardioCel Neo Bioscaffold Patch 4 cm X 4 cm Lemaitre Vascular, Inc.DXZ2024-10-10
00840663110667VascuCel Bioscaffold Patch .8 cm X 8 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110674VascuCel Bioscaffold Patch 1 cm X 14 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110773CardioCel Neo Bioscaffold Patch 5 cm X 8 cmLemaitre Vascular, Inc.DXZ2024-10-10
00840663110544CardioCel Bioscaffold Patch 2 cm X 2 cmLemaitre Vascular, Inc.DXZ2024-10-08
20705031462202ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462219ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462226ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462233ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462240ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462257ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462264ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462271ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462288ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462301ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462318ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462325ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462332ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462349ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462356ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462363ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462370ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462387ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462394ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
20705031462400ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
30705031239788ETHIBOND EXCELETHICON, LLCDXZ2018-01-31