Onatec OEX1

GUDID 10848782039439

Onalene Polypropylene 10-0 16cm & 6-0 8cm

Surgical Specialties México, S. de R.L. de C.V.

Polyolefin suture, monofilament
Primary Device ID10848782039439
NIH Device Record Key1463acd6-e5be-450f-9661-871d745f17a7
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnatec
Version Model NumberOEX1
Catalog NumberOEX1
Company DUNS812762226
Company NameSurgical Specialties México, S. de R.L. de C.V.
Device Count1
DM Exempttrue
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+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com
Phone+1(877)991-1110
Emailservice@surgicalspecialties.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100848782039432 [Primary]
GS110848782039439 [Package]
Contains: 00848782039432
Package: Box [5 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSuture, nonabsorbable, synthetic, polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-05
Device Publish Date2022-04-27

On-Brand Devices [Onatec]

10848782040350Onalene Polypropylene blue 10-0, 10cm, Straight, 1 arm
10848782040343Onalene Polypropylene blue 9-0, 10cm, Straight, 1 arm
10848782040374Onalene Polypropylene blue 10-0 20CM 1-4 Circle 2 arms
10848782040367Onalene Polypropylene blue 9-0 10CM 1-4 Circle 1 arm
10848782033017DLZL-6.2-150schlank9/0 PA Nylon black 15cm
10848782033000HLZ-5.0-100 9/0 PA Nylon black 20cm
10848782032997DLZL-11-330 7/0 PA Nylon Black 45cm
10848782032966DLZL-13-350 6/0 PA Nylon black 45cm
108487820329592x DLZL-11-350 6/0 PA Nylon black 45cm
10848782032942DLZL-11-330 6/0 PA Nylon black 45cm
10848782032935DDSL-9.4-200 6/0 PA Nylon black 45cm
10848782032911DLZL-16-430 5/0 PA Nylon black 45cm
10848782032874DLZL-19-530 4/0 PA Nylon black 45cm
10848782032867DRS-4.0-70 11/0 PA Nylon black 15cm
10848782032850DDS-6.5-150 10/0 PA Nylon black 15cm
10848782032843DRS-5.1-70 10/0 PA Nylon black 20cm
10848782032836DRS-5.0-100 10/0 PA Nylon black 10cm
10848782006011Onalon Nylon 10-0, 2 arm(s) 2xBLZ-4,8-150 10/0 20 cm Nylon
10848782006004Onalon Nylon 5-0, 2 arm(s) 2xVLZ-8,5-450 5/0 45 cm Nylon
10848782005991Onalon Nylon 7-0, 1 arm(s) VLZL-6,4-200 7/0 30 cm Nylon
10848782005984Onalon Nylon 10-0, 2 arm(s) 2xVLZ-4,8-150 10/0 30 cm Nylon
10848782005977Onalon Nylon 10-0, 2 arm(s) 2xDLZL-62-150 10/0 30 cm Nylon
10848782005960Onalon Nylon 10-0, 1 arm(s) DLZL-6,2-150 10/0 8 cm Nylon
10848782005953Onalon Nylon 10-0, 1 arm(s) DLZL-6,2-150 10/0 15 cm Nylon
10848782005946Onalon Nylon 9-0, 2 arm(s) 2xDLZL-6,2-150 9/0 30 cm Nylon
10848782005939Onalon Nylon 8-0, 1 arm(s) DLZ-6,2-150 8/0 15 cm Nylon
10848782005922Onalon Nylon 11-0, 1 arm(s) DLZ-6,2-150 11/0 10cm Nylon
10848782005915Onalon Nylon 10-0, 2 arm(s), 2xHLZL-5,6-150 10/0 30 cm Nylon
10848782005908Onalon Nylon 10-0, 1 arm(s) HLZL-5,6-150 10/0 15 cm Nylon
10848782005892Onalon Nylon 6-0, 1 arm(s) DLZL-16-430 6/0 45 cm Nylon
10848782005885Onalon Nylon 4-0, 1 arm(s) DLZL-16-430 4/0 45 cm Nylon
10848782005878Onalon Nylon 5-0, 1 arm(s) DLZL-13-430 5/0 45 cm Nylon
10848782005861Onalon Nylon 4-0, 2 arm(s) 2xDLZL-13-430 4/0 45 cm Nylon
10848782005854Onalon Nylon 4-0, 1 arm(s) DLZL-13-430 4/0 45 cm Nylon
10848782005847Onalon Nylon 7-0, 1 arm(s) HDK-8,0-230 7/0 30 cm Nylon
10848782005830Onalon Nylon 7-0, 1 arm(s) HDK-8,0-230 P 7/0 30 cm loop Nylon
10848782005823Onalon Nylon 6-0, 2 arm(s) 2xHDK-8,0-300 6/0 30 cm Nylon
10848782005816Onalon Nylon 5-0, 2 arm(s) 2xHDK-8,0-300 5/0 30 cm Nylon
10848782005809Onalon Nylon 4-0, 1 arm(s) HDK-18-550 4/0 45 cm Nylon
10848782005793Onalon Nylon 6-0, 1 arm(s) DDSL-6,4-200 6/0 20 cm Nylon
10848782005786Onalon Nylon 10-0, 1 arm(s) DDS-5,1-100 10/0 15 cm Nylon
10848782005779Onalon Nylon 9-0, 1 arm(s) DDS-5,1-100 9/0 15 cm Nylon
10848782005762Onalon Nylon 4-0, 1 arm(s) HDS-18-430 4/0 75 cm Nylon
10848782005755Onalon Nylon 10-0, 1 arm(s) DRS-6,4-140 10/0 15 cm Nylon
10848782005748Onalon Nylon 9-0, 1 arm(s) DRS-6,4-140 9/0 15 cm Nylon
10848782005731Onalon Nylon 8-0, 1 arm(s) DRS-6,4-150 8/0 15 cm Nylon
10848782005595Onalon Nylon 10-0, 2 arm(s) 2xDRS-5,1-70 10/0 2,5 cm Nylon
10848782005588Onalon Nylon 10-0, 1 arm(s) DRS-5,1-100 10/0 15 cm Nylon
10848782005571Onalon Nylon 9-0, 1 arm(s) DRS-5,1-100 9/0, 15 cm Nylon
10848782005564Onalon Nylon 8-0, 1 arm(s) DRS-5,1-150 8/0, 15 cm Nylon

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