SurgiWrap 27504-01

GUDID 00810057380198

Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L-lactide). To be used wherever temporary wound support is required, to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result. Minimizes tissue attachments to the device in case of direct contact with the viscera. Indicated for open and laparoscopic procedures.

MAST BIOSURGERY USA INC.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 00810057380198
• NIH Device Record Key: c3790f0b-a547-4750-b79e-d43c53defc25
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SurgiWrap
• Version Model Number: 130 x 200 x 0.05mm
• Catalog Number: 27504-01
• Company DUNS: 188582360
• Company Name: MAST BIOSURGERY USA INC.
• Device Count: 1
• 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: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com
• Phone: 866-627-8246
• Email: CustomerService@mastbio.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810057380198 [Primary]
GS1	00810057380204 [Package]; Package: 5 unit box [5 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K050332

FDA Product Code

• FTL: Mesh, Surgical, Polymeric

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-11-10

On-Brand Devices [SurgiWrap]

• 00810057380198: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 00810057380181: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 00810057380167: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L
• 00810057380136: Bioresorbable protective sheet made from polylactide: a copolymer of 70:30 Poly(L-lactide-co-D,L