GENESIS ALL SUTURE ANCHOR 10JS2503

GUDID 00850005827290

2.5MM ALL SUTURE ANCHOR, SH

Genesis Biologics, Inc.

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00850005827290
NIH Device Record Key9c083a68-c15f-4fba-aef3-1e54a46ed524
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENESIS ALL SUTURE ANCHOR
Version Model Number10JS2503
Catalog Number10JS2503
Company DUNS016463487
Company NameGenesis Biologics, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM
Phone(657) 888-6243
EmailORDERS@GENESISBIOLOGICS.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100850005827290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-24
Device Publish Date2023-03-16

Devices Manufactured by Genesis Biologics, Inc.

00850005827214 - GENESIS SCREW-IN SUTURE ANCHOR2023-03-24 4.5MM SCREW-IN SUTURE ANCHOR
00850005827221 - GENESIS SCREW-IN SUTURE ANCHOR2023-03-24 5.5MM SCREW-IN SUTURE ANCHOR
00850005827238 - GENESIS SCREW-IN SUTURE ANCHOR2023-03-24 6.5MM SCREW-IN SUTURE ANCHOR
00850005827245 - GENESIS THREAD SCREW-IN SUTURE ANCHOR2023-03-24 4.75MM DUAL THREAD SCREW-IN SUTURE ANCHOR
00850005827252 - GENESIS THREAD SCREW-IN SUTURE ANCHOR2023-03-24 5.5MM DUAL THREAD SCREW-IN SUTURE ANCHOR
00850005827269 - GENESIS PUSH-IN SUTURE ANCHOR2023-03-24 3.0MM PUSH-IN SUTURE ANCHOR
00850005827276 - GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR2023-03-24 4.75MM HYBRID KNOTLESS DUAL THREAD ANCHOR
00850005827283 - GENESIS HYBRID KNOTLESS DUAL THREAD ANCHOR2023-03-24 5.5MM HYBRID KNOTLESS DUAL THREAD ANCHOR
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