SafeGuide® 1214-03D

GUDID 10816734020996

Cleaning Brush - Single Use

DIVERSATEK HEALTHCARE, INC.

Surgical instrument/endoscope cleaning brush/tool, single-use Surgical instrument/endoscope cleaning brush/tool, single-use Surgical instrument/endoscope cleaning brush/tool, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use Surgical instrument/endoscope cleaning utensil, single-use

• Primary Device ID: 10816734020996
• NIH Device Record Key: 5dff36e4-513b-4c4f-b091-f2058784b5e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeGuide®
• Version Model Number: 1214-03D
• Catalog Number: 1214-03D
• Company DUNS: 030650113
• Company Name: DIVERSATEK HEALTHCARE, 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: 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: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com
• Phone: 800-558-6408
• Email: sales@diversatekhc.com

Device Dimensions

• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter
• Length: 86 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734020999 [Primary]
GS1	10816734020996 [Package]; Contains: 00816734020999; Package: Case [3 Units]; In Commercial Distribution

FDA Product Code

• KNQ: Dilator, Esophageal

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2020-06-29
• Device Publish Date: 2016-09-17

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• 00816734021194: Esophageal Dilatation System
• 00816734021187: Esophageal Dilator, 60 French
• 00816734021170: Esophageal Dilator, 57 French
• 00816734021163: Esophageal Dilator, 54 French
• 00816734021156: Esophageal Dilator, 51 French
• 00816734021149: Esophageal Dilator, 48 French
• 00816734021132: Esophageal Dilator, 45 French
• 00816734021125: Esophageal Dilator, 42 French
• 00816734021118: Esophageal Dilator, 39 French
• 00816734021101: Esophageal Dilator, 36 French
• 00816734021095: Esophageal Dilator, 33 French
• 00816734021088: Esophageal Dilator, 30 French
• 00816734021071: Esophageal Dilator, 27 French
• 00816734021064: Esophageal Dilator, 24 French
• 00816734021057: Esophageal Dilator, 21 French
• 00816734021040: Esophageal Dilator, 18 French
• 00816734021033: Esophageal Dilator, 15 French
• 00816734021019: Cleaning Brush - Reusable
• 10816734021009: Cleaning Brush - Reusable
• 10816734020996: Cleaning Brush - Single Use
• 00816734020982: Guidewire with Spring Tip
• 10816734020972: Guidewire with Spring Tip
• 10816734021023: Cleaning Adapters