OcciGuide 048-1000

GUDID M710ERGUIDE1010

BIOTEX, INC.

Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable needle guide, single-use Nonimplantable 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 Needle guide, single-use

• Primary Device ID: M710ERGUIDE1010
• NIH Device Record Key: cbfdf399-758e-4f2e-98f8-e5c4a762b0cf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OcciGuide
• Version Model Number: ER GUIDE 1010
• Catalog Number: 048-1000
• 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: 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: 7137410111
• Email: xx@xx.xx
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Operating and Storage Conditions

• 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
• 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
• 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	M710ERGUIDE1010 [Primary]

FDA Product Code

• GDF: Guide, Needle, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-02-28
• Device Publish Date: 2020-02-20

On-Brand Devices [OcciGuide]

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