ComPel OR Gown

GUDID 00634916788358

2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body

STANDARD TEXTILE CO., INC.

Surgical gown, reusable

• Primary Device ID: 00634916788358
• NIH Device Record Key: e588475f-c1c2-42de-af58-71509190be02
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel OR Gown
• Version Model Number: 75647454
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00634916788358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041539

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

[00634916788358]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-10-18
• Device Publish Date: 2023-10-10

Devices Manufactured by STANDARD TEXTILE CO., INC.

• 00634916707038 - Pediatric Lap Drape: 2023-10-18 Pediatric Lap Drape, 1 Ply WrapPel Ripstop Body, 29x34 Reinforcement Bound Pad (1 Ply Zorwick II, 1 Ply ComPel), 6" Triangular B
• 00634916788358 - ComPel OR Gown: 2023-10-182-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body
• 00634916788358 - ComPel OR Gown: 2023-10-18 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Nec
• 00634916795493 - ProMax Surgical Gown: 2023-10-18 ProMax Surgical Gown, MLR Front Yoke, Comfort Panel Back with Negastat, Snap Closures at Neck, Tape Tie Closures at Waist, With
• 00634916857535 - ComPel Isolation Gown: 2023-10-18 Isolation Gown, ComPel, Yellow, Raglan Sleeves, Metal Snaps at Neck and Waist, Elastic Sleeve Opening and Thumb Loop
• 00634916790528 - Isolation Gown EasyRelease: 2023-08-22 Isolation Gown EasyRelease, AAMI Level 1, generic polyester, Yellow, XL, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves
• 10634916508960 - DermaTherapy Fitted Sheet: 2023-07-28 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around, 37x79x10
• 10634916578710 - DermaTherapy Fitted Sheet: 2023-07-28 DermaTherapy Fitted Sheet, 50% Polyester / 50% Nylon, Encased Elastic Hem all Around with Blue Thread, 35x84x11
• 00634916796780 - Isolation Gown: 2023-07-03 Isolation Gown, AAMI Level 2, Reusable, 100% Polyester, Tie Closures Neck and Waist, Raglan Sleeves with Poly Cuffs