GARRETT VASCULAR DILATOR

GUDID B09927000380

GARRETT VASCULAR DILATOR

SONTEC INSTRUMENTS, INC.

Vascular dilator, reusable

• Primary Device ID: B09927000380
• NIH Device Record Key: 610316b0-5ce8-4998-ae5f-beca9c40fc35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GARRETT VASCULAR DILATOR
• Version Model Number: 2700-038
• Company DUNS: 040729840
• Company Name: SONTEC INSTRUMENTS, 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: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com
• Phone: 303-790-9411
• Email: info@sontecinstruments.com

Device Dimensions

• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch
• Length: 5.5 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00192896005884 [Primary]
HIBCC	B09927000380 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100518

FDA Product Code

• DWP: Dilator, Vessel, Surgical

Sterilization

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

[B09927000380]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09927000380]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

[B09927000380]

Moist Heat or Steam Sterilization;Dry Heat Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-09-21
• Device Publish Date: 2018-08-21

On-Brand Devices [GARRETT VASCULAR DILATOR]

• B09927000500: GARRETT VASCULAR DILATOR SOFT MALLEABLE SET OF 3
• B09927000230: GARRETT VASCULAR DILATOR
• B09927000200: GARRETT VASCULAR DILATOR SET OF 3
• B09927000530: GARRETT VASCULAR DILATOR
• B09927000520: GARRETT VASCULAR DILATOR
• B09927000510: GARRETT VASCULAR DILATOR
• B09927000390: GARRETT VASCULAR DILATOR
• B09927000380: GARRETT VASCULAR DILATOR
• B09927000370: GARRETT VASCULAR DILATOR
• B09927000360: GARRETT VASCULAR DILATOR
• B09927000350: GARRETT VASCULAR DILATOR
• B09927000340: GARRETT VASCULAR DILATOR
• B09927000330: GARRETT VASCULAR DILATOR
• B09927000320: GARRETT VASCULAR DILATOR
• B09927000310: GARRETT VASCULAR DILATOR
• B09927000300: GARRETT VASCULAR DILATOR SET OF 9
• B09927000220: GARRETT VASCULAR DILATOR
• B09927000210: GARRETT VASCULAR DILATOR
• B0992700010P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000100: GARRETT VASCULAR DILATOR
• B0992700009P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000090: GARRETT VASCULAR DILATOR
• B0992700008P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000080: GARRETT VASCULAR DILATOR
• B0992700007P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000070: GARRETT VASCULAR DILATOR
• B0992700006P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000060: GARRETT VASCULAR DILATOR
• B0992700005P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000050: GARRETT VASCULAR DILATOR
• B0992700004P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000040: GARRETT VASCULAR DILATOR
• B0992700003P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000030: GARRETT VASCULAR DILATOR
• B0992700002P0: GARRETT VASCULAR DILATOR ARROW TIP
• B09927000020: GARRETT VASCULAR DILATOR
• B09927000010: GARRETT VASCULAR DILATOR SOFT MALLEABLE SET OF 9
• 00192896105072: Garrett Vascular Dilator Arrow Tip
• 00192896105065: Garrett Vascular Dilator Arrow Tip
• 00192896105089: Garrett Vascular Dilator Arrow Tip