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

• Primary Device ID: 35413765589646
• NIH Device Record Key: 250bb87b-7e1d-4648-b701-7ed5bd1655ee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SEPRAFILM
• Version Model Number: 638001
• Catalog Number: 638001
• Company DUNS: 005083209
• Company Name: BAXTER HEALTHCARE CORPORATION
• Device Count: 4
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com
• Phone: +1(800)933-0303
• Email: medinfo_medproducts@baxter.com

Device Dimensions

• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch
• Width: 2.5 Inch
• Length: 3 Inch

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05413765589645 [Primary]
GS1	35413765589646 [Package]; Contains: 05413765589645; Package: PK [10 Units]; In Commercial Distribution
GS1	75413765589644 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950034

FDA Product Code

• MCN: Barrier, absorbable, adhesion

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-18
• Device Publish Date: 2021-06-10

On-Brand Devices [SEPRAFILM]

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