BioBrace BB35X25

GUDID 20653405990137

BioBrace® Reinforced Implant, 35 x 25 mm

Conmed Corporation

Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Primary Device ID20653405990137
NIH Device Record Key41a12006-f739-40e7-b8bd-a5f6751c0cc6
Commercial Distribution StatusIn Commercial Distribution
Brand NameBioBrace
Version Model NumberBB35X25
Catalog NumberBB35X25
Company DUNS071595540
Company NameConmed Corporation
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(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com
Phone+1(866)426-6633
EmailCustomerExperience@conmed.com

Device Dimensions

Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter
Length25 Millimeter
Width35 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110653405990130 [Primary]
GS120653405990137 [Package]
Contains: 10653405990130
Package: Pouch [1 Units]
In Commercial Distribution

FDA Product Code

OWYMesh, surgical, collagen, orthopaedics, reinforcement of tendon

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


[20653405990137]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-30
Device Publish Date2024-09-20

On-Brand Devices [BioBrace]

10653405988960BioBrace Reinforce BioInductive Implant, 23 x 30 mm
10653405988953BioBrace Reinforce BioInductive Implant, 23 x 30 mm
10653405988939BioBrace Reinforce BioInductive Implant, 5 x 250 mm
20653405990151BioBrace® Reinforced Implant, Foot & Ankle, 40 x 60 mm
20653405990144BioBrace® Reinforced Implant, 40 x 60 mm
20653405990137BioBrace® Reinforced Implant, 35 x 25 mm
20653405990120BioBrace® Reinforced Implant, 23 x 25 mm

Trademark Results [BioBrace]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIOBRACE
BIOBRACE
88322262 not registered Live/Pending
Biorez, Inc.
2019-03-01
BIOBRACE
BIOBRACE
87245826 5232413 Live/Registered
Raven Computer Inc.
2016-11-22
BIOBRACE
BIOBRACE
78423516 not registered Dead/Abandoned
MEDI BAYREUTH GMBH & CO. KG
2004-05-23
BIOBRACE
BIOBRACE
77349610 3772206 Dead/Cancelled
BioBrace LLC
2007-12-11

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