Promax Backless Pathology Gown 75674166

GUDID 00634916684919

Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua MLR Panel with Negastat Backs, Color Coded Tie Closures at Neck & Waist, Poly Cuffs, Size Medium

STANDARD TEXTILE CO., INC.

Surgical gown, reusable

• Primary Device ID: 00634916684919
• NIH Device Record Key: 3d3e01f1-b47b-4903-bfee-759751aca511
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promax Backless Pathology Gown
• Version Model Number: 75674166
• Catalog Number: 75674166
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 24
• 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: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com
• Phone: 1-800-999-0400
• Email: GUDID@standardtextile.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916684919 [Primary]
GS1	10634916684916 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041540

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

[00634916684919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-04-13
• Device Publish Date: 2020-04-03

On-Brand Devices [Promax Backless Pathology Gown]

• 00634916684926: Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua M
• 00634916684919: Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua M
• 00634916684896: Promax Backless Pathology Gown, 1-Ply Front Aqua ProMax, 2-Ply Aqua ProMax Sleeves, 1-Ply Aqua M