Primary Device ID | 00801741233708 |
NIH Device Record Key | 97329db6-4dd0-4471-92d6-07ca3d415628 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GalaFLEX |
Version Model Number | GP0408BD |
Catalog Number | GP0408BD |
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 |
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 |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
Width | 10 Centimeter |
Length | 20 Centimeter |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00801741233708 [Primary] |
OOD | surgical film |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2025-10-03 |
Device Publish Date | 2025-09-25 |
00801741233715 | GalaFlex Scaffold, 15.0 cm x 20.0 cm, Rectangle |
00801741233708 | GalaFlex Scaffold, 10.0 cm x 20.0 cm, Rectangle |
00801741233692 | GalaFlex Scaffold, 5.0 cm x 20.0 cm, Rectangle |
00801741233685 | GalaFlex Scaffold, 5.0 cm x 15.0 cm, Rectangle |
00801741233678 | GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() GALAFLEX 85273670 4301942 Live/Registered |
GALATEA SURGICAL, INC. 2011-03-22 |
![]() GALAFLEX 85197843 not registered Dead/Abandoned |
GENOMMA LAB INTERNACIONAL, S.A.B. DE C.V. 2010-12-14 |
![]() GALAFLEX 72143407 0748771 Dead/Expired |
KIEFER K. G. 1962-04-30 |