Sequel Medical IM1600003F

GUDID 00810071321542

10mm Flex Head Spanner

Sequel Medical Inc.

External orthopaedic fixation system, single-use, non-sterile

• Primary Device ID: 00810071321542
• NIH Device Record Key: b676eee6-9788-48e9-ac60-af93a99d2631
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sequel Medical
• Version Model Number: IM1600003F
• Catalog Number: IM1600003F
• Company DUNS: 109935591
• Company Name: Sequel Medical Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com
• Phone: 858-863-3826
• Email: hdang@sequelmd.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810071321542 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202833

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

[00810071321542]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-24
• Device Publish Date: 2021-08-16

On-Brand Devices [Sequel Medical]

• 00810071321658: Foot Ring Long 200 mm
• 00810071321641: Foot Ring Long 180 mm
• 00810071321634: Foot Ring Long 160 mm
• 00810071321627: FOOT RING LONG 140MM
• 00810071321610: Foot Ring Short 200 mm
• 00810071321603: Foot Ring Short 180 mm
• 00810071321597: Foot Ring Short 160 mm
• 00810071321580: Foot Ring Short 140 mm
• 00810071321498: Universal Bolt
• 00810071321481: Pivot Cube
• 00810071321474: Pin Sleeve 6 mm
• 00810071321467: Pin Sleeve 5 mm
• 00810071321450: 6 hole Cube
• 00810071321443: 5 hole Cube
• 00810071321436: 4 hole Cube
• 00810071321429: 3 hole Cube
• 00810071321412: 2 hole Cube
• 00810071321405: 1 hole Cube
• 00810071321399: Spatial Hinge - Female
• 00810071321382: Spatial Hinge - Male
• 00810071321375: Uniaxial Hinge - Female
• 00810071321368: Uniaxial Hinge - Male
• 00810071321351: spherical Carding
• 00810071321344: Hinge with Slotted Mounting
• 00810071321337: Hinged Distractor
• 00810071321320: Ring Spacer 40mm
• 00810071321313: Ring Spacer 30mm
• 00810071321306: Ring Spacer 20mm
• 00810071321290: Oblique Support Connection 90mm
• 00810071321283: Oblique Support Connection 60mm
• 00810071321276: Oblique Support Connection 30mm
• 00810071321269: 4.8mm Drill w/6mm Shank
• 00810071321252: 3.8mm Drill w/6mm Shank
• 00810071321245: Wire Tensioners
• 00810071321238: Wire Cutter Angled
• 00810071321221: Box wrench for Bolt 10mm
• 00810071321214: Box Wrench Open Ended
• 00810071321207: Combination Wrench 10mm
• 00810071321191: Dual Row Foot Plate 180 mm
• 00810071321184: Dual Row Foot Plate 160 mm
• 00810071321177: Dual Row Foot Plate 140 mm
• 00810071321139: 6 Tab Full Ring 180mm
• 00810071321122: 6 Tab Full Ring 160mm
• 00810071321115: 6 Tab Full Ring 140mm
• 00810071321108: 6 Tab Half Ring 180mm
• 00810071321092: 6 Tab Half Ring 160mm
• 00810071321085: 6 Tab Half Ring 140mm
• 00810071321047: Full Ring 180mm
• 00810071321030: Full Ring 160mm
• 00810071321023: Full Ring 140mm