FDA.report

DEKNATEL

Primary DI
34026704634195
Brand
DEKNATEL
Company
TELEFLEX INCORPORATED
Model
IPN029131
Catalog number
X-4528
Device description
PLEDGET SOFT 3/4"X3/8"X1/16" X2
Published
2018-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Product Code Classifications

CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
34026704634195PackageGS136In Commercial Distribution
04026704426645PreviousGS10
14026704634191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
3402670463419534026704634195
04026704426645040267044266454026704426645
1402670463419114026704634191

GMDN Terms

TermDefinition
Cardiovascular patch, syntheticA sterile 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

TypeValueUnit
Length75Centimeter

Sterilization Methods

Method

Contacts

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 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 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