SCANLAN® Minimally-Invasive Instrumentation 9009-522-01

GUDID 00846159033618

Thoracoscopic DeBakey Fcp 5mm, axial Hdle, 2.5mm cvd jaws, w/o rat, 20cm WL, 14-1/4"/36cm TL

SCANLAN INTERNATIONAL INC

Rigid endoscopic tissue manipulation forceps, reusable

• Primary Device ID: 00846159033618
• NIH Device Record Key: 943de0dc-f37c-43a2-bad6-3a213020bd1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SCANLAN® Minimally-Invasive Instrumentation
• Version Model Number: 9009-522-01
• Catalog Number: 9009-522-01
• 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: 651-297-0997
• Email: vanderpoelw@scanlangroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00846159033618 [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

[00846159033618]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2019-08-21
• Device Publish Date: 2018-04-23

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