Scanlan® A/C LOCATOR® graft markers 1001-83B

GUDID 00846159025651

U-shaped style, silicone, bulk NS, 10 per pk

SCANLAN INTERNATIONAL INC

Polymeric coronary bypass marker

• Primary Device ID: 00846159025651
• NIH Device Record Key: 3b64a25c-fc78-4d0f-aa18-fefef60ddbe9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Scanlan® A/C LOCATOR® graft markers
• Version Model Number: 1001-83B
• Catalog Number: 1001-83B
• Company DUNS: 023055619
• Company Name: SCANLAN INTERNATIONAL INC
• Device Count: 10
• DM Exempt: true
• Pre-market Exempt: true
• MRI Safety Status: MR Safe
• 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: 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	00084615902943 [Unit of Use]
GS1	00846159025651 [Primary]

FDA Product Code

• MAB: Marker, Cardiopulmonary Bypass (Vein Marker)

Sterilization

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

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

[00846159025651]

Ethylene Oxide

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-08-27

Devices Manufactured by SCANLAN INTERNATIONAL INC

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• 00846159023053 - SCANLAN® Minimally Invasive Instrumentation: 2025-02-10 Endoscopic Fine Needle Holder curved 5mm w/ratchet DD jaws 9-3/4"/24.8cm
• 00846159036251 - SCANLAN® Titanium Neuro Forceps: 2025-02-10 Micro Suture Tying Fcp, RH, Gerald type taper, str 0.3 mm DD tips, 6"/15 cm
• 00846159036268 - SCANLAN® Titanium Neuro Forceps: 2025-02-10 Micro Suture Tying Fcp, RH, Gerald type taper, 0.3mm DD tips, 7-1/4"/18.5cm
• 00846159036275 - SCANLAN® Titanium Neuro Forceps: 2025-02-10 Micro Suture Tying Fcp, RH, Gerald taper, curv 0.3mm DD tips, 7-1/4"/18.5cm
• 00846159036282 - Scanlan Titanium Bayonet Forceps: 2025-02-10 Scanlan Micro Fcp, fh, bayo sty, 0.3mm curved up, DD tips, 8-3/4"/22 cm
• 00846159036299 - SCANLAN® Micro Suture Tying Forceps: 2025-02-10 Micro Suture Tying Forceps, RH, 45°angl, 0.3mm DD tips, 5-1/2"/14cm FS