GalaFLEX LITE GFLT0515BD
GUDID 00801741233739
GalaFlex LITE Scaffold, 5.0 cm x 15.0 cm, Rectangle
Davol Inc.
Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable| Primary Device ID | 00801741233739 |
| NIH Device Record Key | 0110c033-f8ec-4225-bb1a-29c2594c9bf8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GalaFLEX LITE |
| Version Model Number | GFLT0515BD |
| Catalog Number | GFLT0515BD |
| 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 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com | |
| Phone | +1(800)562-0027 |
| medical.services@bd.com |
Device Dimensions
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
| Width | 5 Centimeter |
| Length | 15 Centimeter |
Operating and Storage Conditions
| 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Do not use if the center of the temperature indicator is black. |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00801741233739 [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 |
Trademark Results [GalaFLEX LITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GALAFLEX LITE 88639540 not registered Live/Pending |
Galatea Surgical, Inc. 2019-10-02 |
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