FDA.reportPublic FDA data

GYNECARE INTERCEED

Primary DI
20705031147840
Brand
GYNECARE INTERCEED
Company
ETHICON, LLC
Model
4350XL
Catalog number
4350XL
Device description
Absorbable Adhesion Barrier, Oxidized Regenerated Cellulose
Published
2014-09-20
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
MCNBARRIER, ABSORABLE, ADHESION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MCNBarrier, Absorbable, AdhesionUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P880047000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880047000INTERCEED TC7 ABSORBABLE ADHESION BARRIERETHICON, Inc.1989-09-15MCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031147840PackageGS110In Commercial Distribution
10705031147843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503114784020705031147840
1070503114784310705031147843

GMDN Terms#

Term, Definition table
TermDefinition
Surgical anti-adhesion dressing, implantable, bioabsorbableA bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue to another following a surgical procedure. The device is typically implanted during abdominal or pelvic surgery to reduce the incidence of adhesions between adjacent anatomical structures. It is typically made of a modified cellulose material.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature030 Degrees Celsius
Storage Environment Temperature086 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
829465157
Device count
1
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
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

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05413765589652SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589615SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589622SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589639SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589646SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
35413765589653SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
00085412086217Adept Adhesion Reduction Solution BAXTER INTERNATIONAL INC.MCN2017-03-23
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00358468430120Seprafilm®GENZYME CORPORATIONMCN2014-09-24
00358468508621Seprafilm® Procedure PackGENZYME CORPORATIONMCN2014-09-24
00358468638014Seprafilm® 4-sectionGENZYME CORPORATIONMCN2014-09-24
00358468664112Seprafilm® Single SiteGENZYME CORPORATIONMCN2014-09-24
00358468664211Seprafilm® Small IncisionGENZYME CORPORATIONMCN2014-09-24
10705031005396GYNECARE INTERCEEDEthicon SàrlMCN2014-09-20
10705031147843GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031005393GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20