FDA.reportPublic FDA data

ETHICON

Primary DI
10705031051058
Brand
ETHICON
Company
ETHICON, LLC
Model
U11T
Catalog number
U11T
Device description
Nonabsorbable Surgical Cotton
Published
2015-09-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FODDEVICE, OCCLUSION, UMBILICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FODDevice, Occlusion, UmbilicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031051055PackageGS124Not in Commercial Distribution
10705031051058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503105105520705031051055
1070503105105810705031051058

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord tapeA thin, flat strip of synthetic and/or natural material which is used as a tie or suture around the umbilical cord of a newborn infant after severance from the placenta. It typically consists of a braided strip of cotton thread and or spun polyester yarn and comes in a variety of sizes. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
079402290
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031001435ETHILON1629H1629H2015-09-01
10705031006393ETHILON585H585H2015-09-01
10705031007703ETHILON661H661H2015-09-01
10705031007789ETHILON663H663H2015-09-01
10705031007918ETHILON669H669H2015-09-01
10705031008724PERMA-HAND706G706G2015-09-01
10705031129931ETHICONW945W9452026-05-18
10705031239777ETHIBOND EXCELX4B37GX4B37G2018-01-25
10705031239784ETHIBOND EXCELX4B77GX4B77G2018-01-31
10705031462144ETHIBOND EXCEL10X52N10X52N2019-07-04
10705031462168ETHIBOND EXCEL10X72N10X72N2019-07-04
10705031462175ETHIBOND EXCEL10X66N10X66N2019-07-04
10705031468214ETHIBOND EXCELD7576ND7576N2021-05-08
10705031468221ETHIBOND EXCELD10048ND10048N2021-05-08
10705031468238ETHIBOND EXCELD7581ND7581N2021-05-08
10705031468245ETHIBOND EXCELD7924ND7924N2021-05-08
10705031468276ETHIBOND EXCELD8492ND8492N2021-05-08
10705031468320ETHIBOND EXCELD9079ND9079N2021-05-08
10705031468344ETHIBOND EXCELD9329ND9329N2021-05-08
10705031468351ETHIBOND EXCELD9607ND9607N2021-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852568002138umbili-CLAMPDivergent Medical Technologies LLcFOD2024-07-18
00852568002152umbili-GRIPDivergent Medical Technologies LLcFOD2024-07-18
00852568002169umbili-CLAMPDivergent Medical Technologies LLcFOD2024-07-18
00852568002190umbili-GRIPDivergent Medical Technologies LLcFOD2024-07-18
00630094064246Bioseal Inc.BIOSEALFOD2024-01-29
00630094064369Bioseal Inc.BIOSEALFOD2024-01-29
00630094064918Bioseal Inc.BIOSEALFOD2024-01-29
00630094068121Bioseal Inc.BIOSEALFOD2024-01-29
00630094068244Bioseal Inc.BIOSEALFOD2024-01-29
00630094068367Bioseal Inc.BIOSEALFOD2024-01-29
00630094068824Bioseal Inc.BIOSEALFOD2024-01-29
00630094680095Bioseal Inc.BIOSEALFOD2024-01-29
10630094064243Bioseal Inc.BIOSEALFOD2024-01-29
10630094064366Bioseal Inc.BIOSEALFOD2024-01-29
10630094064915Bioseal Inc.BIOSEALFOD2024-01-29
10630094068128Bioseal Inc.BIOSEALFOD2024-01-29
10630094068241Bioseal Inc.BIOSEALFOD2024-01-29
10630094068364Bioseal Inc.BIOSEALFOD2024-01-29
10630094068821Bioseal Inc.BIOSEALFOD2024-01-29
10630094680092Bioseal Inc.BIOSEALFOD2024-01-29
00810124990008SDP Inc.Sdp Inc. Specialite De Produits DermatologiquesFOD2023-07-06
10810124990005SDP Inc.Sdp Inc. Specialite De Produits DermatologiquesFOD2023-07-06
10888277804708Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FOD2022-08-04
40888277804709Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FOD2022-08-04
00840216105003ASP MEDICALAsp Global, LLCFOD2022-07-29
00840216105010ASP MEDICALAsp Global, LLCFOD2022-07-29
M75257015210STRADIS HEALTHCARESTRADIS MEDICAL, LLCFOD2022-04-06
M75257015220STRADIS HEALTHCARESTRADIS MEDICAL, LLCFOD2022-04-06
M75257015200STRADIS HEALTHCARESTRADIS MEDICAL, LLCFOD2022-03-02
00749756138451DeRoyalDEROYAL INDUSTRIES, INC.FOD2021-07-12