GENESIS PUSH-IN SUTURE ANCHOR 10S30002

GUDID 00850005827269

3.0MM PUSH-IN SUTURE ANCHOR

Genesis Biologics, Inc.

Tendon/ligament bone anchor, bioabsorbable
Primary Device ID00850005827269
NIH Device Record Key84e75ca3-3f75-4e5a-8a25-f97941a75dd4
Commercial Distribution StatusIn Commercial Distribution
Brand NameGENESIS PUSH-IN SUTURE ANCHOR
Version Model Number10S30002
Catalog Number10S30002
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
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
GS100850005827269 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAIFastener, Fixation, Biodegradable, 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.

00850005827368 - AlternatiV+ Screw-In Anchor2024-10-16 4.75MM SCREW-IN SUTURE ANCHOR
00850005827375 - AlternatiV+ Screw-In Anchor2024-10-16 5.5MM SCREW-IN SUTURE ANCHOR
00850005827382 - AlternatiV+ Max Knotless Anchor2024-10-16 4.75MM MAX KNOTLESS ANCHOR
00850005827399 - DUAL PITCH AWL/TAPPER 4.75MM2024-10-16 DUAL PITCH AWL/TAPPER 4.75MM
00850005827405 - DUAL PITCH AWL/TAPPER 5.5MM2024-10-16 DUAL PITCH AWL/TAPPER 5.5MM
00850005827412 - AWL/TAPPER 4.5MM2024-10-16 AWL/TAPPER 4.5MM
00850005827429 - AWL 4.5MM2024-10-16 AWL 4.5MM
00850005827436 - AWL 5.5MM2024-10-16 AWL 5.5MM

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