NovoStitch

GUDID 00853541006082

NovoStitch Plus Meniscal Repair System

Ceterix Orthopaedics

Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use Arthroscopic surgical procedure kit, non-medicated, single-use
Primary Device ID00853541006082
NIH Device Record Key168c1556-6e92-496b-87db-8dcb4b779c65
Commercial Distribution StatusIn Commercial Distribution
Brand NameNovoStitch
Version Model NumberCTX-A002
Company DUNS054774944
Company NameCeterix Orthopaedics
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com
Phone1-650-241-1748
Emailinfo@ceterix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100853541006082 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-05-07

On-Brand Devices [NovoStitch]

00853541006167NovoStitch Disposable Suture Passer
00853541006112NovoStitch Pro Meniscal Repair System
00853541006105NovoStitch Meniscal Repair Cartridge
00853541006082NovoStitch Plus Meniscal Repair System
00853541006068NovoStitch Meniscal Repair Cartridge, Size 0
00853541006051NovoStitch Pro Meniscal Repair System, CTX-A004 (Size 0)

Trademark Results [NovoStitch]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NOVOSTITCH
NOVOSTITCH
85900717 4548945 Live/Registered
CETERIX ORTHOPAEDICS, INC.
2013-04-10

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