Rotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Large

GUDID 00854501006012

ROTATION MEDICAL, INC.

Multi-purpose surgical mesh, collagen, bioabsorbable
Primary Device ID00854501006012
NIH Device Record Keye9eba96f-5206-40ae-b086-c031630d3e66
Commercial Distribution StatusIn Commercial Distribution
Brand NameRotation Medical Reconstituted Collagen Scaffold - Arthroscopic, Large
Version Model Number2169-3
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 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100854501006012 [Primary]

FDA Product Code

ORQMesh, Surgical, Deployer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-10-23

Devices Manufactured by ROTATION MEDICAL, INC.

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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
00854501006173 - Bone Anchors with Arthroscopic Delivery System2019-03-21
00854501006067 - Rotation Medical Tendon Staples2019-01-08

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