FDA.reportPublic FDA data

GYNECARE INTERCEED

Primary DI
10705031147843
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
MR Safe
Rx
true
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
P880047020

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P880047000INTERCEED TC7 ABSORBABLE ADHESION BARRIERETHICON, Inc.1989-09-15MCN
P880047020INTERCEED 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 material, implantable, bioabsorbable, non-medicatedA bioabsorbable, surgically-implanted device intended to prevent the abnormal fibrous union (adhesion) between one internal body part/tissue and another following a surgical procedure; neither antimicrobials nor pharmaceuticals are included. It may be supplied as a barrier membrane, hydratable gel, or fluid dressing and is made of appropriate material (e.g., collagen- or hyaluronic acid-based) to reduce adhesion between adjacent anatomical structures.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
829465157
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031472143Coated VICRYLVCP814DVCP814D2026-05-08
10705031472174MONOCRYLMCP2543GMCP2543G2026-05-08
10705031472181MONOCRYLMCP507GMCP507G2026-05-08
10705031472198MONOCRYLMCP895HMCP895H2026-05-08
10705031024748ETHILOND3116D31162015-09-23
10705031026643ETHILOND6661D66612015-09-23
10705031027084ETHILOND7018D70182015-09-23
10705031030138ETHILOND8420D84202015-09-23
10705031030558ETHILOND8555D85552015-09-23
10705031032743ETHILOND9336D93362015-09-23
10705031033474ETHILOND9537D95372015-09-23
10705031148161ETHICONESS15ESS152015-09-24
10705031001589ETHILON1647G1647G2015-09-01
10705031002050ETHILON1683H1683H2015-09-01
10705031002135ETHILON1691H1691H2015-09-01
10705031002173ETHILON1697H1697H2015-09-01
10705031002241ETHILON1714G1714G2015-09-01
10705031002258ETHILON1716G1716G2015-09-01
10705031002739ETHILON1845G1845G2015-09-01
10705031003927ETHILON2800G2800G2015-09-01

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Primary DI, Brand, Company table
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03770016478052Womed LeafWOMEDMCN2025-12-24
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05413765589621SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589638SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
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05413765589652SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
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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
20705031147840GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031005393GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20