SCANLAN® Minimally-Invasive Instrumentation 9009-828-02

GUDID 00846159024562

SCANLAN® Minimally-Invasive Knot Pusher

SCANLAN INTERNATIONAL INC

Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable Suturing unit, reusable

• Primary Device ID: 00846159024562
• NIH Device Record Key: f835501e-f19f-4181-a423-4304e02f9407
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® Minimally-Invasive Instrumentation
• Version Model Number: 9009-828-02
• Catalog Number: 9009-828-02
• Company DUNS: 023055619
• Company Name: SCANLAN INTERNATIONAL INC
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com
• Phone: 651-298-0997
• Email: vanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846159024562 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K945474

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

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

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

[00846159024562]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-01
• Device Publish Date: 2021-05-24

On-Brand Devices [SCANLAN® Minimally-Invasive Instrumentation]

• 00846159034806: SCANLAN® Thoracoscopic Knot Pusher
• 00846159034790: SCANLAN® Thoracoscopic Knot Pusher
• 00846159034783: SCANLAN® Minimally-Invasive Dissector
• 00846159034776: SCANLAN® Minimally-Invasive Dissector
• 00846159034769: SCANLAN® Minimally-Invasive Dissector
• 00846159034752: SCANLAN® Minimally-Invasive Dissector
• 00846159033625: Thoracoscopic DeBakey Clamp 10mm, ang jaws, 21cm WL, 12"/30.5cm TL
• 00846159033618: Thoracoscopic DeBakey Fcp 5mm, axial Hdle, 2.5mm cvd jaws, w/o rat, 20cm WL, 14-1/4"/36cm TL
• 00846159033168: Thoracoscopic Foerster Clamp, 20mm, DCJ, 42CM TL, W/Ratchet, 32CM WL
• 00846159013085: SCANLAN® Thoracoscopic Duval Clamp
• 00846159032376: Thor Duval Clamp, Custom, 15 5/8"
• 00846159011173: Thoracoscopic Needle Holder, 7mm, old ring handle, curved carbon inlay jaws, 13.5” / 34 cm
• 00846159011166: Thoracoscopic Needle Holder, 7mm, gold ring handle, straight carbon inlay jaws, 13.5” / 34 cm
• 00846159011159: CardioVasive™ Fine Needle Holder (5 mm), Ring Handle, Diamond Dust™ jaw, (1 cm jaw length
• 00846159026535: SCANLAN® Suture Puller
• 00846159028775: SCANLAN® Chitwood Dissecting Scissors
• 00846159035247: Thoracoscopic Dissecting Scissors, Curved, 10" / 25.4 cm
• 00846159035216: SCANLAN® Thoracoscopic Chitwood Dissecting Scissors
• 00846159032345: Chitwood Dissecting Scissors coated shaft
• 00846159035186: Thorascopic Pleurectomy Spatula
• 00846159035179: Thorascopic Pleurectomy Spatula
• 00846159029055: Thoracoscopic Foerster Clamp, 2X Oval J 13-1/4"
• 00846159025507: Thoracoscopic Chitwood DeBakey Clamp,10mm, rnghdl,1x2 curvlft 7cm DeBak jaws,ang shks,6 3/4"
• 00846159025491: Thoracoscopic Chitwood DeBakey Clamp,10mm, rnghdl,1x2 curv rt 7 cm DeBak jaws,10 3/8" / 26.4cm
• 00846159025484: Thoracoscopic Chitwood DeBakey Forcep,5mm,round axial handle,8mm knurl, 2.5 mm straight Debakey
• 00846159024852: THORACOSCOPIC FOERSTER CLAMP, L, 10MM, RH, 19 CM WORKING LNGTH, 11 1/2"/ 29 CM
• 00846159024777: Thoracoscopic Foerster Clamp, 25D, 10 mm, 13"
• 00846159024760: Thoracoscopic Foerster Clamp, 10mm, 11 1/2"
• 00846159016611: Thor DeBakey Fcp, axial design, RH, 3.5 mm tips,w/ratchet, 14-1/4"/36.5cm
• 00846159016604: Thor DeBakey Fcp, axial design, RH, 3.5 mm tips,w/o ratchet,14-1/4"/36.5cm
• 00846159016598: Thor DeBakey Fcp, axial design, RH, 2.5 mm tips,w/ ratchet, 14-1/4"/36.5cm
• 00846159016581: Thor DeBakey Fcp, axial design, RH, 2.5 mm tips,w/o ratchet,14-1/4"/36.5cm
• 00846159016574: Thor DeBakey Fcp, axial design, RH, 1.5 mm tips,w/ratchet, 14-1/4"/36.5cm
• 00846159016567: Thor DeBakey Fcp, axial design, RH, 1.5 mm tips,w/o ratchet, 14-1/4"/36.5cm
• 00846159016550: Thor Platform Fcp, axial desn, RH, 2mm DD pltfm tips,w/rat,14-1/4"/36.5cm
• 00846159016543: Thor Platform Fcp, axial desn, RH, 2mm DD pltfm tips,w/o rat,14-1/4"/36.5cm
• 00846159016536: Thor Russian Fcp, axial design, RH, 6 mm tips, with ratchet, 14-1/4"/36.5cm
• 00846159016529: Thor Russian Fcp, axial design, RH, 6 mm tips, w/o ratchet, 14-1/4"/36.5 cm
• 00846159016512: Thor Resano Fcp, axial design,RH,multi-tooh tips, w/ratchet, 14-1/4"/36.5cm
• 00846159016505: Thor Resano Fcp, axial design,RH,multi-tooth tips, w/o rat, 14-1/4"/36.5cm
• 00846159011739: Thoracoscopic Duval Clamp, 10mm,rng hdle,curv lft 2.5cm triang ring jaws,13-1/2" / 34cm
• 00846159011722: Thoracoscopic Foerster Clamp,10mm, rnghdl,curvlft 20mm oval ring jaws,13-1/4"/33 cm
• 00846159011715: Thoracoscopic Chitwood DeBakey Clamp (10 mm), ring handle, 1x2 curved left DeBakey jaws, 10 cm j
• 00846159011708: CardioVasive™ Chitwood DeBakey Clamp (10 mm), 2x3 wide Debakey Jaw, Curved Left, (10 cm jaw le
• 00846159011685: CardioVasive™ Chitwood DeBakey Clamp, 10mm, 45 degree angled left, (12.7 cm jaw length; 27.5 w
• 00846159011678: Thoracoscopic Harken #2 Clamp, 10mm, 1x2 DeBakey jaw, 14" / 35.5 cm
• 00846159011661: Thoracoscopic DeBakey Clamp, 10 mm, ring handle, 1x2 straight jaw
• 00846159011654: Thoracoscopic DeBakey Cooley Forceps, without ratchet, 90° jaw, 10 mm
• 00846159002829: Thoracoscopic Duval Clamp, 10mm, rng hdle, curv lft 1cm triang ring jaws,13-1/2" / 34cm
• 00846159002812: CardioVasive™ Thoracoscopic DeBakey Cooley Clamp, 10mm, 90°angle jaw (6.5 cm jaw length; 23 c