SEPRAFILM 638001

GUDID 35413765589646

Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC).

BAXTER HEALTHCARE CORPORATION

Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated Surgical anti-adhesion material, implantable, bioabsorbable, non-medicated
Primary Device ID35413765589646
NIH Device Record Key250bb87b-7e1d-4648-b701-7ed5bd1655ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameSEPRAFILM
Version Model Number638001
Catalog Number638001
Company DUNS005083209
Company NameBAXTER HEALTHCARE CORPORATION
Device Count4
DM Exemptfalse
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(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com
Phone+1(800)933-0303
Emailmedinfo_medproducts@baxter.com

Device Dimensions

Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
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Width2.5 Inch
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Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
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Width2.5 Inch
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Width2.5 Inch
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Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
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Width2.5 Inch
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Width2.5 Inch
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Width2.5 Inch
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Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch
Width2.5 Inch
Length3 Inch

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
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
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
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
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
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
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
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
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
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
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
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105413765589645 [Primary]
GS135413765589646 [Package]
Contains: 05413765589645
Package: PK [10 Units]
In Commercial Distribution
GS175413765589644 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MCNBarrier, absorbable, adhesion

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-18
Device Publish Date2021-06-10

On-Brand Devices [SEPRAFILM]

35413765589653Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier
35413765589646Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier
35413765589639Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier
35413765589622Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier
35413765589615Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier

Trademark Results [SEPRAFILM]

Mark Image

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

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