Biodesign Additae C-HHR-7X10-U

GUDID 10827002515793

Biodesign Additae Hiatal Hernia Graft

COOK BIOTECH INCORPORATED

Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Multi-purpose surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial Extra-gynaecological surgical mesh, collagen, bioabsorbable, non-antimicrobial
Primary Device ID10827002515793
NIH Device Record Key17deca1b-c1e9-4dbc-90af-a32b2baf529d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiodesign Additae
Version Model NumberG51579
Catalog NumberC-HHR-7X10-U
Company DUNS945385862
Company NameCOOK BIOTECH INCORPORATED
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 Datetrue
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(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com
Phone+1(812)330-5494
Emailsharedservices@cookmedical.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in a clean, dry location at room temperature.
Storage Environment TemperatureBetween 10 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002515796 [Primary]
GS110827002515793 [Package]
Contains: 00827002515796
Package: Each [1 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTMMesh, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-24
Device Publish Date2021-11-16

On-Brand Devices [Biodesign Additae]

10827002592879Biodesign Additae Hiatal Hernia Graft
10827002515793Biodesign Additae Hiatal Hernia Graft
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