Onatec OE172081

GUDID 10848782040343

Onalene Polypropylene blue 9-0, 10cm, Straight, 1 arm

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

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament

• Primary Device ID: 10848782040343
• NIH Device Record Key: 1d25d288-8dfa-45a9-b798-69c0067b854e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Onatec
• Version Model Number: OE172081
• Catalog Number: OE172081
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00848782040346 [Primary]
GS1	10848782040343 [Package]; Contains: 00848782040346; 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: 2021-04-13
• Device Publish Date: 2021-04-05

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