ComPel MLR Surgical Gown

GUDID 10634916797166

Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Ply Aqua MLR Comfort Panel Backs, X-Large

STANDARD TEXTILE CO., INC.

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• Primary Device ID: 10634916797166
• NIH Device Record Key: 468ebe00-dc60-44db-9a7f-c4e212fe575c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ComPel MLR Surgical Gown
• Version Model Number: 75674914
• 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	00634916797169 [Primary]
GS1	10634916797166 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K041541

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

[10634916797166]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-17
• Device Publish Date: 2021-06-09

On-Brand Devices [ComPel MLR Surgical Gown]

• 00634916311921: OR GWN CMPL MLR KAUM AQUA 2XL - RM (98 8130) USE: 75670243
• 00634916310245: OR Gown ComPel MLR 2PLY AQUA 4XL - SNPS @ NK/TT WST
• 00634916298765: OR GWN CMPL MLR KAUM AQUA XL - RM (98 8130) USE: 7567R244
• 00634916298673: OR GWN CMPL MLR 2PLY AQUA XL
• 00634916296884: OR GWN CMPL MLR KAUM AQUA L - RM (98 8130) USE: 7567R245
• 00634916294880: OR GOWN COMPEL MLR 2PLY AQUA L
• 00634916249101: OR GWN COMPEL MLR 2PLY AQUA L/XL
• 00634916247305: OR GWN CMPL MLR KAUM AQUA L - RM (98 7806) USE: 7567B215
• 00634916191899: OR GWN CMPL MLR KAUM AQUA L/XL - RM (98 8130) USE:7567B2R4
• 00634916191769: OR GWN CMPL MLR 2PLY AQUA L/XL
• 00634916187618: OR GWN COMPL MLR KAUM AQUA 2XL - RM (98 8130) USE: 7567B163
• 00634916187601: OR GWN COMPEL MLR KAUM AQUA XL - RM (98 8130) USE: 7567B164
• 00634916187595: OR GWN COMPEL MLR KAUM AQUA L - RM (98 8130) USE: 7567B165
• 00634916178968: OR GWN CMPL ULT MLR AQUA 3XL - MS @ NK/WST
• 00634916110999: OR GWN CMPL MLR 2PLY AQUA 2XL - SNPS @ NK/TT WST
• 00634916110982: OR GWN CMPL MLR 2PLY AQUA XL - SNPS @ NK/TT WST
• 00634916098396: OR GWN CMPL MLR AQUA 2XL/3XL - 2PLY MS @ NK/TT WST (SR 14686)
• 00634916088526: SURGICAL GWN MLR CMPL AQUA XL - SNAP NK/TIE WST AQUA CUFFS
• 00634916074109: OR GWN CMPL MLR 2PLY KAUM 2X A - RM (98 7647) USE: 7567B213
• 00634916074093: OR GWN CMPL MLR 2PLY KAUM L AQ
• 00634916028058: OR GWN CMPL MLR 2PLY AQUA 4XL - SNPS @ NK/TT WST W/INV SLVS
• 00634916011838: OR GWN CMPL MLR 2PLY AQUA 2XL - SNPS @ NK/TT WST W/INV SLVS
• 00634916011821: OR GWN CMPL MLR 2PLY AQUA XL - SNPS @ NK/TT WST W/INV SLVS
• 00634916011814: OR GWN CMPL MLR 2PLY AQUA L - SNPS @ NK/TT WST W/INV SLVS
• 00634916011432: OR GWN COMPEL MLR AQUA 2XL - 2PLY TT @ NK/WST W/INV SLVS
• 00634916011135: OR GWN COMPEL MLR AQUA XL - 2PLY TT @ NK/WST W/INV SLVS
• 00634916011128: OR GWN COMPEL MLR AQUA L - 2PLY TT @ NK/WST W/INV SLVS
• 00634916010282: OR GWN CMPL ULT MLR AQUA 2XL - MS @ NK/WST
• 00634916010275: OR GWN CMPL ULT MLR AQUA M - MS
• 00634916009620: OR GWN CMPL ULT MLR AQUA L - MS @ NK/WST
• 00634916009613: OR GWN CMPL ULT MLR AQUA XL - MS @ NK/WST
• 00634916709674: ComPel MLR Surgical Gown, 2-Ply Front, Circumferentially Offset Sleeves, Aqua Compel MLR Outer S
• 00634916496963: ComPel MLR Backless Pathology Gown, 1-Ply Front Aqua, 2-Ply sleeves, size XL
• 00634916496956: ComPel MLR Backless Pathology Gown, 1-Ply Front Aqua, 2-Ply sleeves, size Medium
• 00634916496949: ComPel MLR Backless Pathology Gown 1-Ply Front, 2-Ply sleeves, size Small
• 10634916797173: Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Pl
• 10634916797166: Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Pl
• 10634916797159: Surgical GWN MLR CMPL 2-Ply Front/Sleeves Aqua Compel MLR and White Compel MLR w/Negastat, 1-Pl