Lac-Mac 005XFAH-3XL

GUDID 00627755571007

Surgical Gown, Level 4, 3 sets grips to knit neckband, tie at waist, patented Size 3XL

Lac-Mac Limited

Surgical gown, reusable

• Primary Device ID: 00627755571007
• NIH Device Record Key: 89a99c34-7d4d-480c-817e-9d43eaf0484e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lac-Mac
• Version Model Number: 005XFAH-3XL
• Catalog Number: 005XFAH-3XL
• Company DUNS: 201276334
• Company Name: Lac-Mac Limited
• 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: true
• Manufacturing Date: true
• 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: false

Customer Support Contacts

• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com
• Phone: 5194322616
• Email: shelley.petrovskis@lac-mac.com

Device Dimensions

• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch
• Height: 57.25 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627755571007 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061491

FDA Product Code

• FYA: Gown, Surgical

Sterilization

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

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

[00627755571007]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-05-15
• Device Publish Date: 2023-05-07

On-Brand Devices [Lac-Mac]

• 06277558400239: Wrapper ,54 X 72, Level 2, Blue Bias Single Ply
• 06277558400222: Wrapper, 54 X 54, Level 2, merrow edged blue thread, two ply
• 06277558400215: Wrapper, 45 X 45, Level 2, merrow edged white thread, two ply
• 06277558400208: Wrapper, 36 X 36, Level 2, merrow edged light blue thread, two ply
• 06277558400192: Wrap, 72 X 60, Level 2, yellow bias, single ply
• 06277558400185: Wrap, 54 X 54, Level 2, red bias, single ply
• 06277558400178: Wrap, 45 X 45, Level 2, mint green bias, single ply
• 06277558400161: Wrap, 20 X 20, Level 2, merrow edged white thread
• 06277558400154: Wrap, 65 X 65, Level 2, merrow edged yellow thread
• 06277558400147: Wrap, 54 X 54, Level 2, merrow edged blue thread
• 06277558400130: Wrap, 45 X 45, Level 2, merrow edged white thread
• 06277558400123: Wrap, 70 X 60, Level 2, merrow edged yellow thread
• 06277558400116: Wrap, 15 X 15, Level 2, merrow edged blue thread
• 06277558400109: Wrap, 24 X 24, Level 2, merrow edged mint thread
• 06277558400093: Wrap, 80 X 60, Level 2, merrow edged black thread
• 06277558400086: Wrap, 18 X 18, Level 2, Merrow edged blue thread
• 06277558400079: Wrap, 30 X 30, Level 2, merrow edged pink thread
• 06277558400062: Wrap, 54 X 54, Level 2, merrow edged red thread
• 06277558400055: Wrap, 45 X 45, Level 2, merrow edged mint thread
• 06277558400048: Wrap, 36 X 36, Level 2, merrow edged light blue thread
• 06277558400031: Wrap, 30 X 30, Level 2, merrow edged yellow thread
• 06277558400024: Wrap, 23 X 23, Level 2, merrow edged grey thread
• 06277558400017: Wrap, 18 X 18, Level 2, merrow edged white thread
• 06277558400000: Wrap, 81 X 60, Level 2, single ply
• 06277552500362: 3000J Mayo Stand Cover
• 06277552500355: 3020K Back Table Cover
• 06277552500348: Head Drape
• 06277552500331: Foot Drape
• 06277552500324: Side Drape
• 06277552500317: Cysto Stirrup Legging, with red bias on top
• 06277552500300: Under Buttocks Drape 44 X 44, Level 4
• 06277552500294: Lithotomy Drape, Level 4,with 6 X 4 Fenestration
• 06277552500287: Cystoscopy Drape Level 4
• 06277552500270: Laparoscopic/Cholecystectomy Drape
• 06277552500263: Caesarian Drape
• 06277552500256: Child Laparotomy Drape, 100 X 72, Level 4
• 06277552500249: Laparotomy Drape, Level 4
• 06277552500232: Back Table Cover, Level 4, 70 X 60, with 56 X 28 Barrier Section
• 06277552500225: Mayo Stand Cover, 53 X 27, Level 4, Customer Supplied Barcode in specified location
• 06277552500218: Extra Large Back Table Cover, 94 X 58, LML Barcode, Barrier 82X27
• 06277552500201: Cardiac Drape 140 X 90, Level 4
• 06277552500195: Large Mayo Stand Cover ,62X27,Level 4,Yellow Bias at top
• 06277552500188: Ring Stand Cover, 51 X 51, LevelL4, Barrier 27X27
• 06277552500171: Extra Large Table Cover, 94 X 58, with customer supplied barcode, barrier 82 X 27
• 06277552500164: Large Split Drape, 110 X 80, Level 4
• 06277552500157: Small Split Drape, 86 X 68, Level 4
• 06277552500140: Medium Sheet, 80 X 60, Mint Bias One End Only
• 06277552500133: Mayo Stand Cover, 54 X 28, Level 4
• 06277552500126: Mayo Stand Cover, 53 X 27, Level 4
• 06277552500119: Mayo Stand Cover, Rounded Bottom, Level 4