GalaFLEX GP0208BD

GUDID 00801741233692

GalaFlex Scaffold, 5.0 cm x 20.0 cm, Rectangle

Davol Inc.

Extra-gynaecological surgical mesh, synthetic polymer, bioabsorbable
Primary Device ID00801741233692
NIH Device Record Key0ac3bbfa-1fb7-400c-a07e-9119ea1d4e56
Commercial Distribution StatusIn Commercial Distribution
Brand NameGalaFLEX
Version Model NumberGP0208BD
Catalog NumberGP0208BD
Company DUNS001191048
Company NameDavol Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com
Phone+1(800)562-0027
Emailmedical.services@bd.com

Device Dimensions

Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter
Length20 Centimeter
Width5 Centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.
Storage Environment TemperatureBetween 15 Degrees Celsius and 25 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Do not use if the center of the temperature indicator is black.

Device Identifiers

Device Issuing AgencyDevice ID
GS100801741233692 [Primary]

FDA Product Code

OODsurgical film

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-10-03
Device Publish Date2025-09-25

On-Brand Devices [GalaFLEX]

00801741233715GalaFlex Scaffold, 15.0 cm x 20.0 cm, Rectangle
00801741233708GalaFlex Scaffold, 10.0 cm x 20.0 cm, Rectangle
00801741233692GalaFlex Scaffold, 5.0 cm x 20.0 cm, Rectangle
00801741233685GalaFlex Scaffold, 5.0 cm x 15.0 cm, Rectangle
00801741233678GalaFLEX Scaffold, 2.5 cm x 7.6 cm, Rectangle

Trademark Results [GalaFLEX]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GALAFLEX
GALAFLEX
85273670 4301942 Live/Registered
GALATEA SURGICAL, INC.
2011-03-22
GALAFLEX
GALAFLEX
85197843 not registered Dead/Abandoned
GENOMMA LAB INTERNACIONAL, S.A.B. DE C.V.
2010-12-14
GALAFLEX
GALAFLEX
72143407 0748771 Dead/Expired
KIEFER K. G.
1962-04-30

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.