Onatec OE461996

GUDID 10848782040374

Onalene Polypropylene blue 10-0 20CM 1-4 Circle 2 arms

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

Polyolefin suture, monofilament

• Primary Device ID: 10848782040374
• NIH Device Record Key: 71bd6f78-9330-45a7-8943-dac172a7566d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onatec
• Version Model Number: OE461996
• Catalog Number: OE461996
• Company DUNS: 812762226
• Company Name: Surgical Specialties México, S. de R.L. de C.V.
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com
• Phone: +1(877)991-1110
• Email: service@surgicalspecialties.com

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Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782040377 [Primary]
GS1	10848782040374 [Package]; Contains: 00848782040377; Package: Box [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131224

FDA Product Code

• GAW: Suture, nonabsorbable, synthetic, polypropylene

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-04-27
• Device Publish Date: 2021-04-19

On-Brand Devices [Onatec]

• 10848782040350: Onalene Polypropylene blue 10-0, 10cm, Straight, 1 arm
• 10848782040343: Onalene Polypropylene blue 9-0, 10cm, Straight, 1 arm
• 10848782040374: Onalene Polypropylene blue 10-0 20CM 1-4 Circle 2 arms
• 10848782040367: Onalene Polypropylene blue 9-0 10CM 1-4 Circle 1 arm
• 10848782033017: DLZL-6.2-150schlank9/0 PA Nylon black 15cm
• 10848782033000: HLZ-5.0-100 9/0 PA Nylon black 20cm
• 10848782032997: DLZL-11-330 7/0 PA Nylon Black 45cm
• 10848782032966: DLZL-13-350 6/0 PA Nylon black 45cm
• 10848782032959: 2x DLZL-11-350 6/0 PA Nylon black 45cm
• 10848782032942: DLZL-11-330 6/0 PA Nylon black 45cm
• 10848782032935: DDSL-9.4-200 6/0 PA Nylon black 45cm
• 10848782032911: DLZL-16-430 5/0 PA Nylon black 45cm
• 10848782032874: DLZL-19-530 4/0 PA Nylon black 45cm
• 10848782032867: DRS-4.0-70 11/0 PA Nylon black 15cm
• 10848782032850: DDS-6.5-150 10/0 PA Nylon black 15cm
• 10848782032843: DRS-5.1-70 10/0 PA Nylon black 20cm
• 10848782032836: DRS-5.0-100 10/0 PA Nylon black 10cm
• 10848782006011: Onalon Nylon 10-0, 2 arm(s) 2xBLZ-4,8-150 10/0 20 cm Nylon
• 10848782006004: Onalon Nylon 5-0, 2 arm(s) 2xVLZ-8,5-450 5/0 45 cm Nylon
• 10848782005991: Onalon Nylon 7-0, 1 arm(s) VLZL-6,4-200 7/0 30 cm Nylon
• 10848782005984: Onalon Nylon 10-0, 2 arm(s) 2xVLZ-4,8-150 10/0 30 cm Nylon
• 10848782005977: Onalon Nylon 10-0, 2 arm(s) 2xDLZL-62-150 10/0 30 cm Nylon
• 10848782005960: Onalon Nylon 10-0, 1 arm(s) DLZL-6,2-150 10/0 8 cm Nylon
• 10848782005953: Onalon Nylon 10-0, 1 arm(s) DLZL-6,2-150 10/0 15 cm Nylon
• 10848782005946: Onalon Nylon 9-0, 2 arm(s) 2xDLZL-6,2-150 9/0 30 cm Nylon
• 10848782005939: Onalon Nylon 8-0, 1 arm(s) DLZ-6,2-150 8/0 15 cm Nylon
• 10848782005922: Onalon Nylon 11-0, 1 arm(s) DLZ-6,2-150 11/0 10cm Nylon
• 10848782005915: Onalon Nylon 10-0, 2 arm(s), 2xHLZL-5,6-150 10/0 30 cm Nylon
• 10848782005908: Onalon Nylon 10-0, 1 arm(s) HLZL-5,6-150 10/0 15 cm Nylon
• 10848782005892: Onalon Nylon 6-0, 1 arm(s) DLZL-16-430 6/0 45 cm Nylon
• 10848782005885: Onalon Nylon 4-0, 1 arm(s) DLZL-16-430 4/0 45 cm Nylon
• 10848782005878: Onalon Nylon 5-0, 1 arm(s) DLZL-13-430 5/0 45 cm Nylon
• 10848782005861: Onalon Nylon 4-0, 2 arm(s) 2xDLZL-13-430 4/0 45 cm Nylon
• 10848782005854: Onalon Nylon 4-0, 1 arm(s) DLZL-13-430 4/0 45 cm Nylon
• 10848782005847: Onalon Nylon 7-0, 1 arm(s) HDK-8,0-230 7/0 30 cm Nylon
• 10848782005830: Onalon Nylon 7-0, 1 arm(s) HDK-8,0-230 P 7/0 30 cm loop Nylon
• 10848782005823: Onalon Nylon 6-0, 2 arm(s) 2xHDK-8,0-300 6/0 30 cm Nylon
• 10848782005816: Onalon Nylon 5-0, 2 arm(s) 2xHDK-8,0-300 5/0 30 cm Nylon
• 10848782005809: Onalon Nylon 4-0, 1 arm(s) HDK-18-550 4/0 45 cm Nylon
• 10848782005793: Onalon Nylon 6-0, 1 arm(s) DDSL-6,4-200 6/0 20 cm Nylon
• 10848782005786: Onalon Nylon 10-0, 1 arm(s) DDS-5,1-100 10/0 15 cm Nylon
• 10848782005779: Onalon Nylon 9-0, 1 arm(s) DDS-5,1-100 9/0 15 cm Nylon
• 10848782005762: Onalon Nylon 4-0, 1 arm(s) HDS-18-430 4/0 75 cm Nylon
• 10848782005755: Onalon Nylon 10-0, 1 arm(s) DRS-6,4-140 10/0 15 cm Nylon
• 10848782005748: Onalon Nylon 9-0, 1 arm(s) DRS-6,4-140 9/0 15 cm Nylon
• 10848782005731: Onalon Nylon 8-0, 1 arm(s) DRS-6,4-150 8/0 15 cm Nylon
• 10848782005595: Onalon Nylon 10-0, 2 arm(s) 2xDRS-5,1-70 10/0 2,5 cm Nylon
• 10848782005588: Onalon Nylon 10-0, 1 arm(s) DRS-5,1-100 10/0 15 cm Nylon
• 10848782005571: Onalon Nylon 9-0, 1 arm(s) DRS-5,1-100 9/0, 15 cm Nylon
• 10848782005564: Onalon Nylon 8-0, 1 arm(s) DRS-5,1-150 8/0, 15 cm Nylon