FDA.report

DeRoyal

Primary DI
50749756038121
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
32-363
Device description
Teflon Felt
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
50749756038121PackageGS150In Commercial Distribution
00749756038126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975603812150749756038121
00749756038126007497560381267497560381260749756038126

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).

Sterilization Methods

Method

Contacts

PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
false
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
50749756033140DeRoyal10-513010-51302023-01-31
50749756392490DeRoyalNP-6006UNP-6006U2026-01-22
50749756397808DeRoyalNP-0080LMDNP-0080LMD2026-01-22
00749756401258DeRoyalSTM2000STM20002026-01-22
50749756401352DeRoyalM60-AP500M60-AP5002026-01-22
50749756401376DeRoyalM60-AP600M60-AP6002026-01-22
50749756401383DeRoyalM60-AP601M60-AP6012026-01-22
50749756401390DeRoyalM60-AP602M60-AP6022026-01-22
50749756401482DeRoyal46-LT19S-01B46-LT19S-01B2026-01-22
50749756401437DeRoyalM70-200PM70-200P2026-01-01
50749756401444DeRoyalM70-200CM70-200C2026-01-01
50749756401451DeRoyalM70-200CNWM70-200CNW2026-01-01
50749756401468DeRoyalM70-200PNWM70-200PNW2026-01-01
50749756394418DeRoyal71-080571-08052025-08-13
50749756396641DeRoyalPH81-010400PH81-0104002025-08-13
50749756397853DeRoyalPH81-020409PH81-0204092025-08-13
50749756397860DeRoyalPH81-020412PH81-0204122025-08-13
00749756399333DeRoyal1-524A-01-CHO1-524A-01-CHO2025-07-30
00749756399340DeRoyal1-524A-02-CHO1-524A-02-CHO2025-07-30
00749756399357DeRoyal1-524A-03-CHO1-524A-03-CHO2025-07-30

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
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30705031239788ETHIBOND EXCELETHICON, LLCDXZ2018-01-31