Promax OR Gowns 75670314

GUDID 00634916141863

OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/TT WST W/BARCODE

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 Surgical gown, reusable

• Primary Device ID: 00634916141863
• NIH Device Record Key: 88523ba4-6b98-4440-a014-33238f4506c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Promax OR Gowns
• Version Model Number: 75670314
• Catalog Number: 75670314
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916141863 [Primary]
GS1	10634916141863 [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

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

[00634916141863]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-10-23
• Device Publish Date: 2018-01-29

On-Brand Devices [Promax OR Gowns]

• 00634916295122: OR GWN PROMAX KAUM AQUA XL - RM (98 8282) USE: 7567P314
• 00634916295115: OR GWN PROMAX KAUM AQUA 2XL - RM (98 8282) USE: 7567P313
• 00634916294972: OR GWN PROMAX KAUM AQUA 2XL - RM (98 8282) USE: 7567P313
• 00634916189575: OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST (SR 16518)
• 00634916147643: OR GWN PROMAX KNIT AQUA XL - SHORT MS @ NK TT WST BARCODE
• 00634916147612: OR GWN PROMAX KAUM AQUA XL - RM (98-8282) MEMORIAL HERMANN
• 00634916147599: OR GWN PROMAX KAUM AQUA 3XL - RM (98-8282) MEMORIAL HERMANN
• 00634916146622: OR GWN PROMAX KNIT AQUA 3XL - SNPS @ NK/TT WST W/BARCODE
• 00634916141870: OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST W/BARCODE
• 00634916141863: OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/TT WST W/BARCODE
• 00634916141801: OR GWN PROMAX KAUM AQUA 2XL - RM (98 6749) USE: 7567P313
• 00634916141795: OR GWN PROMAX KAUM AQUA XL - RM (98 6749) USE: 7567P314
• 00634916139310: OR GWN PROMAX KNIT AQUA 2XL - MLR FRONT SNPS TTIES @ WST
• 00634916139303: OR GWN PROMAX KNIT AQUA XL - MLR FRONT SNPS TTIES @ WST
• 00634916139297: OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS (SR 15936)
• 00634916086683: OR GWN PROMAX KNIT AQUA 2XL - MLR FRONT SNPS @ NK/TT WST
• 00634916086676: OR GWN PROMAX KNIT AQUA XL - MLR FRONT SNPS @ NK/TT WST
• 00634916086669: OR GWN PROMAX KNIT AQUA L - MLR FRONT SNPS @ NK/TT WST
• 00634916081428: OR GWN XLN PROMAX KNIT AQUA 2X - SNPS @ NK/TT WST (SR 13868)
• 00634916042528: OR GWN PROMAX KNIT AQUA L - SNPS @ NK/WST (S/R 12087)
• 00634916042511: OR GWN PROMAX KNIT AQUA XL - SNPS @ NK/WST