OcciGuide ER GUIDE 1010

GUDID M710ERGUIDE10102

BIOTEX, INC.

Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use Needle guide, single-use

• Primary Device ID: M710ERGUIDE10102
• NIH Device Record Key: 8355a55c-cf72-4bc0-9e36-5272cc1626a7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OcciGuide
• Version Model Number: 048-1000
• Catalog Number: ER GUIDE 1010
• Company DUNS: 969792050
• Company Name: BIOTEX, 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: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx
• Phone: 7137410111
• Email: xx@xx.xx

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Handling Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius
• Storage Environment Temperature: Between -40 Degrees Celsius and 121 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M710ERGUIDE10100 [Primary]
HIBCC	M710ERGUIDE10102 [Package]; Contains: M710ERGUIDE10100; Package: Shelf carton [10 Units]; In Commercial Distribution

FDA Product Code

• GDF: Guide, Needle, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-17
• Device Publish Date: 2021-02-25

On-Brand Devices [OcciGuide]

• M710ERGUIDE1010: ER GUIDE 1010
• M710ERGUIDE10052: 048-1001
• M710ERGUIDE10102: 048-1000