Standard Supreme Surgical Wrapper

GUDID 00634916341348

Standard Supreme Surgical Wrapper, 2-Ply, Merrowed All Around with Color Coded Thread, 54x90

STANDARD TEXTILE CO., INC.

Sterilization packaging, reusable

• Primary Device ID: 00634916341348
• NIH Device Record Key: 8683e477-fe08-4bb1-a5d7-5d9026e1890e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Standard Supreme Surgical Wrapper
• Version Model Number: 21548290
• Company DUNS: 006999858
• Company Name: STANDARD TEXTILE CO., INC.
• Device Count: 1
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916341348 [Primary]

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

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

[00634916341348]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-11
• Device Publish Date: 2023-05-03

Devices Manufactured by STANDARD TEXTILE CO., INC.

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• 00634916788112 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown 2-Ply Front/Sleeves, Tie, 100% POLYESTER.
• 00634916788129 - Compel MLR OR Gown: 2026-03-19 Compel MLR OR Gown, 2-Ply Front/Sleeves, Tie 100% POLYESTER