Bone Anchors with Arthroscopic Delivery System - Advanced 4403

GUDID 00854501006159

ROTATION MEDICAL, INC.

Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID00854501006159
NIH Device Record Keyb44573ad-5733-4f61-b0a3-9f9aa054b259
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Anchors with Arthroscopic Delivery System - Advanced
Version Model Number4403
Catalog Number4403
Company DUNS031098401
Company NameROTATION MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
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

Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com
Phone1-800-821-5700
EmailGUDID@smith-nephew.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100854501006159 [Primary]

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-03-21
Device Publish Date2018-01-09

Devices Manufactured by ROTATION MEDICAL, INC.

00885556735657 - Bioinductive Implant with Arthroscopic Delivery System - Medium2019-08-28
00885556735664 - Bioinductive Implant with Arthroscopic Delivery System - Large2019-08-28
00854501006043 - Rotation Medical Arthroscopic Implant Set With Staples2019-03-21
00854501006074 - Rotation Medical Bone Staple Drivers With Staples2019-03-21
00854501006111 - Rotation Medical Bone Staple 2019-03-21
00854501006159 - Bone Anchors with Arthroscopic Delivery System - Advanced2019-03-21
00854501006159 - Bone Anchors with Arthroscopic Delivery System - Advanced2019-03-21
00854501006173 - Bone Anchors with Arthroscopic Delivery System2019-03-21
00854501006067 - Rotation Medical Tendon Staples2019-01-08

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