FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756115544
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-1326
Device description
PTFE Felt
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
50749756115549PackageGS1100In Commercial Distribution
00749756115544PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975611554950749756115549
00749756115544007497561155447497561155440749756115544

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).

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756401944DeRoyal46-LT5S-0546-LT5S-052026-05-14
00749756998857DeRoyal99-021399-02132019-11-09
00749756998864DeRoyal99-021499-02142019-11-09
00749756998871DeRoyal99-021599-02152019-11-09
00749756998888DeRoyal99-021699-02162019-11-09
00749756998901DeRoyal99-021799-02172019-11-09
00749756998918DeRoyal99-021899-02182019-11-09
00749756998925DeRoyal99-021999-02192019-11-09
00749756998956DeRoyal99-022099-02202019-11-09
00749756998963DeRoyal99-022199-02212019-11-09
00749756998970DeRoyal99-022299-02222019-11-09
00749756998642DeRoyal99-021199-02112021-05-07
00749756401685DeRoyalNP-7DAYKITUTSNP-7DAYKITUTS2026-04-02
00749756401951DeRoyal46-LT20S-0446-LT20S-042026-04-02
00749756401968DeRoyal46-LT19S-0446-LT19S-042026-04-02
00749756402033DeRoyal46-LB5546-LB552026-04-02
00749756879699DeRoyal1104SPP1104SPP2026-04-02
00749756879705DeRoyal1104MPP1104MPP2026-04-02
00749756879712DeRoyal1104LPP1104LPP2026-04-02
00749756879729DeRoyal1104XLPP1104XLPP2026-04-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
14026704634504DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-21
14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646767DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
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
14026704638564DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638571DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
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
14026704634818DEKNATELTELEFLEX INCORPORATEDDXZ2018-07-30