Promax Backless Pathology Gown 75674164

GUDID 00634916684926

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 X-Large

STANDARD TEXTILE CO., INC.

Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable Surgical gown, reusable

• Primary Device ID: 00634916684926
• NIH Device Record Key: a73cfca9-3d89-4b1e-a2ed-bc8d1aba86a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promax Backless Pathology Gown
• Version Model Number: 75674164
• Catalog Number: 75674164
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916684926 [Primary]
GS1	10634916684923 [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

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

Moist Heat or Steam Sterilization

[00634916684926]

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