Seprafilm® Procedure Pack

GUDID 00358468508621

Barrier, Absorbable, Adhesion

GENZYME CORPORATION

Surgical anti-adhesion dressing, implantable, bioabsorbable

• Primary Device ID: 00358468508621
• NIH Device Record Key: 98eaa8a8-5b49-4ae4-a57a-48727fe71263
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Seprafilm® Procedure Pack
• Version Model Number: 5086-02
• Company DUNS: 943130096
• Company Name: GENZYME CORPORATION
• Device Count: 5
• DM Exempt: true
• 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(508)661-1471
• Email: brian.nelson@genzyme.com
• Phone: +1(508)661-1471
• Email: brian.nelson@genzyme.com
• Phone: +1(508)661-1471
• Email: brian.nelson@genzyme.com
• Phone: +1(508)661-1471
• Email: brian.nelson@genzyme.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Area/Surface Area: 585 Square centimeter
• Device Size Text, specify: 0
• Area/Surface Area: 585 Square centimeter
• Device Size Text, specify: 0
• Area/Surface Area: 585 Square centimeter
• Device Size Text, specify: 0

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00358468508621 [Primary]
GS1	30358468508622 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P950034

FDA Product Code

• MCN: BARRIER, ABSORABLE, ADHESION

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-09-10
• Device Publish Date: 2014-09-24

Devices Manufactured by GENZYME CORPORATION

• 00358468000071 - GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US: 2022-10-27 GAA-1 ANTIBODY 1MG/1ML MEDSU VL1 DIAG US
• 00358468000057 - NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U: 2020-07-09 NEOGAA AVALGLUCO 103MG/20ML MEDSU VL1 U
• 00358468000064 - OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US: 2020-07-09 OLIPUDASE 20MG/5ML MEDSU VL1 DIAG US
• 00358468430120 - Seprafilm®: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468508621 - Seprafilm® Procedure Pack: 2019-09-10Barrier, Absorbable, Adhesion
• 00358468508621 - Seprafilm® Procedure Pack: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468638014 - Seprafilm® 4-section: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468664112 - Seprafilm® Single Site: 2019-09-10 Barrier, Absorbable, Adhesion
• 00358468664211 - Seprafilm® Small Incision: 2019-09-10 Barrier, Absorbable, Adhesion