Seprafilm®

GUDID 00358468430120

Barrier, Absorbable, Adhesion

GENZYME CORPORATION

Surgical anti-adhesion dressing, implantable, bioabsorbable
Primary Device ID00358468430120
NIH Device Record Key3fad5a16-8aee-4c98-847f-8ce872d72565
Commercial Distribution StatusIn Commercial Distribution
Brand NameSeprafilm®
Version Model Number4301-02
Company DUNS943130096
Company NameGENZYME CORPORATION
Device Count10
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(508)271-3304
Emailpaul.dawidczykjr@genzyme.com
Phone+1(508)271-3304
Emailpaul.dawidczykjr@genzyme.com
Phone+1(508)271-3304
Emailpaul.dawidczykjr@genzyme.com
Phone+1(508)271-3304
Emailpaul.dawidczykjr@genzyme.com

Device Dimensions

Area/Surface Area195 Square centimeter
Area/Surface Area195 Square centimeter
Device Size Text, specify0
Area/Surface Area195 Square centimeter
Device Size Text, specify0
Area/Surface Area195 Square centimeter
Device Size Text, specify0
Area/Surface Area195 Square centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100358468430120 [Primary]
GS130358468430121 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCNBARRIER, ABSORABLE, ADHESION

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-09-10
Device Publish Date2014-09-24

Devices Manufactured by GENZYME CORPORATION

00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U
00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
00358468430120 - Seprafilm®2019-09-10Barrier, Absorbable, Adhesion
00358468430120 - Seprafilm®2019-09-10 Barrier, Absorbable, Adhesion
00358468508621 - Seprafilm® Procedure Pack2019-09-10 Barrier, Absorbable, Adhesion
00358468638014 - Seprafilm® 4-section2019-09-10 Barrier, Absorbable, Adhesion
00358468664112 - Seprafilm® Single Site2019-09-10 Barrier, Absorbable, Adhesion
00358468664211 - Seprafilm® Small Incision2019-09-10 Barrier, Absorbable, Adhesion

Trademark Results [Seprafilm]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SEPRAFILM
SEPRAFILM
75894972 2511164 Live/Registered
Genzyme Corporation
2000-01-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.