FDA.reportPublic FDA data

Premipatch

Primary DI
04038653961146
Brand
Premipatch
Company
B BRAUN SURGICAL SA
Model
C0027995
Catalog number
C0027995
Device description
PREMIPATCH 6 PFTE FIRM PLEDGETS 6X3MM
Published
2015-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
04046955471935PackageGS130In Commercial Distribution
04038653961146PrimaryGS10
04046963017477Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955471935040469554719354046955471935
04038653961146040386539611464038653961146
04046963017477040469630174774046963017477

GMDN Terms#

Term, Definition table
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#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
511268005
Device count
36
DM exempt
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04046964732546MONOMAXB0041004B00410042018-05-03
04038653926190SteelexG0992100G09921002015-08-20
04046955081417OPTILENEB3095923B30959232022-10-04
04046955081653OPTILENEC3090272C30902722022-10-04
04046955081714OPTILENEC3090304C30903042022-10-04
04046964617331MONOSYNC2022015C20220152018-05-03
04046964618635MONOSYNC2022215C20222152018-05-03
04046964623615MONOSYNC2023424C20234242018-05-03
04046963043780DAFILONB0938920B09389202022-03-09
04046963117856DAFILONB0935890B09358902022-03-09
04046963929848DAFILONB0938905B09389052022-03-09
04046963042455DAFILONB0931640B09316402022-03-09
04046963043384DAFILONB0935739B09357392022-03-09
04038653945849SafilG1048388G10483882015-08-23
04046964028410MonomaxB9972005B99720052015-08-11
04046964028434MonomaxB9941967B99419672015-08-11
04046964028458MonomaxB9972004B99720042015-08-11
04046964028472MonomaxB9941966B99419662015-08-25
04046964066764MonomaxB9941249B99412492015-08-25
04046964066788MonomaxB9941258B99412582015-08-11

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