Standard Supreme Wrapper (hemmed) 21538212

GUDID 00634916343229

WRAPPER T-180 JADE 54X72 2PLY - HEMMED W/SALMON THRD (SR13191)

STANDARD TEXTILE CO., INC.

Sterilization packaging, reusable

• Primary Device ID: 00634916343229
• NIH Device Record Key: 8a73c6aa-7b9f-409f-ab08-9b0fa5a60fbf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Supreme Wrapper (hemmed)
• Version Model Number: 21538212
• Catalog Number: 21538212
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 36
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916343229 [Primary]
GS1	10634916343229 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172207

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

[00634916343229]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-11-08
• Device Publish Date: 2018-01-29

On-Brand Devices [Standard Supreme Wrapper (hemmed)]

• 00634916343229: WRAPPER T-180 JADE 54X72 2PLY - HEMMED W/SALMON THRD (SR13191)
• 00634916343212: WRAPPER T-180 JADE 35X35 2PLY - HEMMED W/BLUE THREAD
• 00634916343205: WRAPPER T-180 JADE 12X12 2PLY - HEMMED W/BLUE THREAD
• 00634916343090: WRAPPER T-180 JADE 24X24 2PLY - HEMMED W/GREEN THREAD
• 00634916343083: WRAPPER T-180 JADE 18X18 2PLY - HEMMED W/LAVENDER THREAD
• 00634916343076: WRAPPER T-180 MTY 35X35 2PLY - HEMMED W/BLUE THREAD
• 00634916343069: WRAPPER T-180 MTY 12X12 2PLY - HEMMED W/BLUE THREAD
• 00634916146301: WRAPPER T180 2PLY 26X72 MISTY - CONCEALED HEMS (SR 15580)
• 00634916010466: WRAPPER T-180 MTY 54X72 2PLY - HEMMED W/CORAL THREAD
• 00634916010381: WRAPPER T-180 MTY 30X30 2PLY - HEMMED/LT PINK
• 00634916000733: WRAPPER T-180 JADE 54X54 2PLY - HEMMED W/GREY THREAD
• 00634916000719: WRAPPER T-180 JADE 45X45 2PLY - HEMMED W/WHITE THREAD
• 00634916000634: WRAPPER T-180 MTY 54X54 2PLY - HEMMED W/GREY THREAD