Biodesign EFPD-0.4

GUDID 00827002236547

Biodesign Enterocutaneous Fistula Plug

COOK BIOTECH INCORPORATED

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 ID00827002236547
NIH Device Record Key28d30461-9133-45a3-8d0a-c0e334f6556f
Commercial Distribution StatusIn Commercial Distribution
Brand NameBiodesign
Version Model NumberG23654
Catalog NumberEFPD-0.4
Company DUNS945385862
Company NameCOOK BIOTECH INCORPORATED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
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(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 clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature
Storage Environment TemperatureBetween 0 Degrees Celsius and 30 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Store in clean, dry location at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100827002236547 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FTMMesh, surgical

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-11-03

On-Brand Devices [Biodesign]

00827002546141Biodesign Fistula Plug
00827002546134Biodesign Fistula Plug
00827002546127Biodesign Fistula Plug
00827002542525Biodesign Staple Line Reinforcement
00827002542518Biodesign Staple Line Reinforcement
00827002536142Biodesign Anal Fistula Plug
00827002525498Biodesign Nipple Reconstruction Cylinder
00827002517462Biodesign Staple Line Reinforcement
00827002508712Biodesign Staple Line Reinforcement
00827002508705Biodesign Staple Line Reinforcement
00827002508682Biodesign Staple Line Reinforcement
00827002508675Biodesign Staple Line Reinforcement
00827002508668Biodesign Staple Line Reinforcement
00827002508651Biodesign Staple Line Reinforcement
00827002506565Biodesign Staple Line Reinforcement
00827002491274Biodesign Nipple Reconstruction Cylinder
00827002491267Biodesign Nipple Reconstruction Cylinder
00827002347908Biodesign Nipple Reconstruction Cylinder
00827002347892Biodesign Nipple Reconstruction Cylinder
00827002250079Biodesign Staple Line Reinforcement
00827002250062Biodesign Staple Line Reinforcement
00827002248274Biodesign Staple Line Reinforcement
00827002236622Biodesign Staple Line Reinforcement
00827002236547Biodesign Enterocutaneous Fistula Plug
00827002236530Biodesign Enterocutaneous Fistula Plug
00827002232013Biodesign Staple Line Reinforcement
10827002583310Tissue Graft
10827002583303Tissue Graft
10827002583297Tissue Graft
10827002583280Tissue Graft
10827002583273Tissue Graft
10827002583976Biodesign Staple Line Reinforcement
10827002583969Biodesign Staple Line Reinforcement
10827002476551Biodesign Peyronie's Repair Graft
10827002476544Biodesign Peyronie's Repair Graft
10827002138084Biodesign 4-Layer Tissue Graft
10827002138077Biodesign 4-Layer Tissue Graft
10827002138060Biodesign 4-Layer Tissue Graft
10827002131160Biodesign 4-Layer Tissue Graft
10827002128481Biodesign 4-Layer Tissue Graft
10827002324371Biodesign Dural Graft
10827002310923Biodesign Dural Graft
10827002310916Biodesign Dural Graft
10827002310909Biodesign Dural Graft
00827002528666Biodesign Plastic Surgery Matrix
00827002528673Biodesign Plastic Surgery Matrix
00827002552678Biodesign Hernia Graft
00827002552661Biodesign Hernia Graft
00827002552654Biodesign Hernia Graft
00827002528659Biodesign Plastic Surgery Matrix

Trademark Results [Biodesign]

Mark Image

Registration | Serial
Company
Trademark
Application Date
BIODESIGN
BIODESIGN
98376229 not registered Live/Pending
Vector Laboratories, Inc.
2024-01-25
BIODESIGN
BIODESIGN
98375749 not registered Live/Pending
Vector Laboratories, Inc.
2024-01-25
BIODESIGN
BIODESIGN
98375633 not registered Live/Pending
Vector Laboratories, Inc.
2024-01-25
BIODESIGN
BIODESIGN
78462571 3065214 Dead/Cancelled
The Queen Family Partnership, LLLP
2004-08-05
BIODESIGN
BIODESIGN
77679942 3704681 Live/Registered
Cook Biotech Incorporated
2009-02-27
BIODESIGN
BIODESIGN
76566578 not registered Dead/Abandoned
Steven M. Montgomery
2003-12-23
BIODESIGN
BIODESIGN
76484445 2990023 Dead/Cancelled
SILIMED - SILICONE E INSTRUMENTAL MÉDICO-CIRÚRGICO E HOSPITALAR LTDA
2003-01-21
BIODESIGN
BIODESIGN
74397569 1827875 Dead/Cancelled
Montgomery, Steven M.
1993-06-04
BIODESIGN
BIODESIGN
74003032 1608949 Dead/Cancelled
BIODESIGN, INC.
1989-11-17

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