FDA.reportPublic FDA data

Seprafilm® Single Site

Primary DI
00358468664112
Brand
Seprafilm® Single Site
Company
GENZYME CORPORATION
Model
6641-01
Device description
Barrier, Absorbable, Adhesion
Published
2014-09-24
Public version status
Update
Distribution status
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
MCNBARRIER, ABSORABLE, ADHESION

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P950034000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P950034000SEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANEBaxter Healthcare Corporation1996-08-12MCN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00358468664112PrimaryGS10
30358468664113Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00358468664112003584686641123584686641120358468664112
3035846866411330358468664113

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area91Square centimeter
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(508)661-1471brian.nelson@genzyme.com
+1(508)271-3304paul.dawidczykjr@genzyme.com

Regulatory Flags#

DUNS number
943130096
Device count
5
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00358468430120Seprafilm®4301-022014-09-24
00358468508621Seprafilm® Procedure Pack5086-022014-09-24
00358468638014Seprafilm® 4-section6380-012014-09-24
00358468664211Seprafilm® Small Incision6642-012014-09-24
00358468000071GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US7626172022-10-19
00358468000057NEOGAA AVALGLUCO 100MG/20ML MEDSU VL1 US7853612020-07-01
00358468000064OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US7853622020-07-01
00358468000019ALDURAZYME 2.9 MG/5ML MEDSU VL1 DIAG US7626182020-06-01
00358468000026MYOZYME 50MG/10ML MEDSU VL1 DIAG US7626192020-06-01
00358468000033FABRAZYME 35MG/7ML VL1 DIAG US7626202020-06-01
00358468000040CEREZYME 400IU MEDSU VL1 DIAG US7626212020-06-01
20358468019114Synvisc-One®0024012014-09-24
00358468019103Synvisc®0023902014-09-25
20358468019039LeGoo® LG100LG1002014-09-24
20358468019046LeGoo® LG250LG2502014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770016478038Womed LeafWOMEDMCN2025-12-24
03770016478045Womed LeafWOMEDMCN2025-12-24
03770016478052Womed LeafWOMEDMCN2025-12-24
05413765589614SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589621SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589638SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
05413765589645SEPRAFILMBAXTER HEALTHCARE CORPORATIONMCN2021-06-10
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
10884521057906SprayShieldCovidien LPMCN2016-04-15
00358468430120Seprafilm®GENZYME CORPORATIONMCN2014-09-24
00358468508621Seprafilm® Procedure PackGENZYME CORPORATIONMCN2014-09-24
00358468638014Seprafilm® 4-sectionGENZYME CORPORATIONMCN2014-09-24
00358468664211Seprafilm® Small IncisionGENZYME CORPORATIONMCN2014-09-24
10705031005396GYNECARE INTERCEEDEthicon SàrlMCN2014-09-20
10705031147843GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031147840GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20
20705031005393GYNECARE INTERCEEDETHICON, LLCMCN2014-09-20