N/A

GUDID 00817438028038

45.0 MM X 13.0 MM X 0.50 MM SAGITTAL BLADE

Omega Surgical Instruments Inc

Surgical saw blade, sagittal, single-use

• Primary Device ID: 00817438028038
• NIH Device Record Key: b5f92d41-caa3-4abb-bbff-c4640aed304d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: N/A
• Version Model Number: SM-4513
• Company DUNS: 808825038
• Company Name: Omega Surgical Instruments Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com
• Phone: 8106959800
• Email: complaints@omegasurgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00817438028038 [Primary]

FDA Product Code

• GFA: Blade, Saw, General & Plastic Surgery, Surgical

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: 2024-07-17
• Device Publish Date: 2024-07-09

On-Brand Devices [N/A]

• 00817438022005: 2.0 MM X 35.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE
• 00817438021992: 1.5 MM X 35.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE
• 00817438027659: 2.5 MM X 170.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438025969: 2.0 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL W/J-NOTCH, 2 FLUTE
• 00817438025952: 2.0 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE
• 00817438025945: 1.5 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL W/J-NOTCH, 2 FLUTE
• 00817438025938: 1.5 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE
• 00817438025921: 1.1 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL W/J-NOTCH, 2 FLUTE
• 00817438025914: 1.1 MM X 51.0 MM WIREPASS STAINLESS STEEL DRILL, 2 FLUTE
• 00817438024276: 4.8 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024269: 4.5 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024252: 4.0 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024245: 3.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024238: 3.2 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024221: 2.8 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024214: 2.4 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024207: 2.0 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024191: 1.6 MM X 125.0 MM STAINLESS STEEL TWIST BRILL BIT, 2 FLUTE
• 00817438024153: 1.8 MM X 100.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024146: 4.5 MM X 145.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024139: 3.5 MM X 110.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024122: 3.2 MM X 145.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024115: 2.8 MM X 185.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024108: 2.7 MM X 100.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024092: 2.5 MM X 110.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024085: 2.5 MM X 95.0 MM STAINLESS STEEL TWIST DRILL BIT, 2 FLUTE, TIN COATED
• 00817438024078: 2.0 MM X 85.0 MM STAINLESS STEEL TWIST DRILL BIT, 2 FLUTE
• 00817438024061: 2.0 MM X 100.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024054: 1.5 MM X 85.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438024047: 1.1 MM X 60.0 MM STAINLESS STEEL TWIST DRILL BIT W/AO QUICK CONNECT, 2 FLUTE
• 00817438023064: 1.5 MM X 4.5 MM X 70.0 MM STOP DRILL WITH J-NOTCH
• 00817438022456: 3.0 MM X 150.0 MM MATCH HEAD NEURO STAINLESS STEEL DRILL, 2 FLUTE
• 00817438024498: 3.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024481: 3.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE
• 00817438024474: 3.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR W/J-NOTCH,8 FLUTE
• 00817438024467: 3.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 8 FLUTE
• 00817438024436: 2.7 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024429: 2.7 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE
• 00817438024412: 2.3 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024405: 2.3 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE
• 00817438024399: 2.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024382: 2.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE
• 00817438024375: 1.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR W/J-NOTCH, 6 FLUTE
• 00817438024368: 1.0 MM X 2.35 MM X 51.0 MM ROUND CARBIDE BUR, 6 FLUTE
• 00817438024351: 1.8 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024344: 1.8 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE
• 00817438024337: 1.5 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024320: 1.5 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE
• 00817438024313: 1.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR W/J-NOTCH, 6 FLUTE
• 00817438024306: 1.0 MM X 2.35 MM X 70.0 MM ROUND STAINLESS STEEL BUR, 6 FLUTE