GalaFLEX LITE GFLT0015BD

GUDID 00801741233777

GalaFlex LITE Scaffold, 15.0 cm, Circle

Davol Inc.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable

• Primary Device ID: 00801741233777
• NIH Device Record Key: 3b84affd-b09b-44bf-8dd9-f5791b42b423
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GalaFLEX LITE
• Version Model Number: GFLT0015BD
• Catalog Number: GFLT0015BD
• Company DUNS: 001191048
• Company Name: Davol Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• 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)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com
• Phone: +1(800)562-0027
• Email: medical.services@bd.com

Device Dimensions

• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter
• Outer Diameter: 15 Centimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius
• Special Storage Condition, Specify: Between 0 and 0 *Do not use if the center of the temperature indicator is black.
• Storage Environment Temperature: Between 15 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00801741233777 [Primary]

FDA Product Code

• OOD: surgical film

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: 2025-10-03
• Device Publish Date: 2025-09-25

On-Brand Devices [GalaFLEX LITE]

• 00801741234019: GalaFlex LITE Scaffold, 25.0 cm x 30.0 cm, Rectangle
• 00801741233852: GalaFlex LITE Scaffold, 20.0 cm x 25.0 cm, Rectangle
• 00801741233838: GalaFlex LITE Scaffold, 25.0 cm, Circle
• 00801741233821: GalaFlex LITE Scaffold, 22.0 cm, Circle
• 00801741233814: GalaFlex LITE Scaffold, 19.0 cm, Circle
• 00801741233791: GalaFlex LITE Scaffold, 15.0 cm x 20.0 cm, Rectangle
• 00801741233784: GalaFlex LITE Scaffold, 17.0 cm, Circle
• 00801741233777: GalaFlex LITE Scaffold, 15.0 cm, Circle
• 00801741233760: GalaFlex LITE Scaffold, 10.0 cm x 20.0 cm, Rectangle
• 00801741233753: GalaFlex LITE Scaffold, 13.0 cm, Circle
• 00801741233746: GalaFlex LITE Scaffold, 5.0 cm x 20.0 cm, Rectangle
• 00801741233739: GalaFlex LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle
• 00801741233722: GalaFlex LITE Scaffold, 2.5 cm x 7.6 cm, Rectangle