Promax Surgical Gown

GUDID 10634916825364

Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size Large

STANDARD TEXTILE CO., INC.

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• Primary Device ID: 10634916825364
• NIH Device Record Key: 6c503e18-a062-4344-8032-2e38b72e1ee2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promax Surgical Gown
• Version Model Number: 75675215
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916825367 [Primary]
GS1	10634916825364 [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

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

[10634916825364]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-22
• Device Publish Date: 2021-12-10

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• 10634916819042: ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Co
• 10634916819035: ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Co
• 10634916819028: ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Co
• 10634916825388: Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size
• 10634916825371: Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size
• 10634916825364: Promax Surgical Gown, 100% Polyester, Twill Tape Closure at Waist, Woven QCM, AAMI Level 4, Size
• 00634916795493: ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, T