SafeGuide® 1214-02

GUDID 10816734020972

Guidewire with Spring Tip

DIVERSATEK HEALTHCARE, INC.

Over-guidewire oesophageal dilator

• Primary Device ID: 10816734020972
• NIH Device Record Key: c00e76db-f5b4-429d-ae1f-d5ceb56add9b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeGuide®
• Version Model Number: 1214-02
• Catalog Number: 1214-02
• 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: false
• 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: 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: 210 Centimeter
• Length: 210 Centimeter
• Length: 210 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816734020975 [Primary]
GS1	10816734020972 [Package]; Contains: 00816734020975; Package: Case [2 Units]; In Commercial Distribution

FDA Product Code

• KNQ: Dilator, Esophageal

Sterilization

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

[10816734020972]

Moist Heat or Steam Sterilization;High-level Disinfectant

[10816734020972]

Moist Heat or Steam Sterilization;High-level Disinfectant

[10816734020972]

Moist Heat or Steam Sterilization;High-level Disinfectant

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-04-10
• Device Publish Date: 2016-09-17

On-Brand Devices [SafeGuide®]

• 10816734021504: Guidewire with Spring Tip - Single Use
• 00816734021200: Esophageal Dilatation System
• 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