Lac-Mac Limited 084E-JK

GUDID 00627755841179

Wrap, 30 X 30, Level 2, merrow edged, pink thread

Lac-Mac Limited

Sterilization packaging, reusable

• Primary Device ID: 00627755841179
• NIH Device Record Key: f2897e01-a144-4a71-93a3-59fc812a4f18
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lac-Mac Limited
• Version Model Number: 084E-JK
• Catalog Number: 084E-JK
• 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

Device Dimensions

• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch
• Length: 30 Inch

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627755841179 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K102864

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

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

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

[00627755841179]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-19
• Device Publish Date: 2024-11-11

Devices Manufactured by Lac-Mac Limited

• 00627755841179 - Lac-Mac Limited: 2024-11-19Wrap, 30 X 30, Level 2, merrow edged, pink thread
• 00627755841179 - Lac-Mac Limited: 2024-11-19 Wrap, 30 X 30, Level 2, merrow edged, pink thread
• 00627755531162 - Lac-Mac: 2024-08-30 Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size M
• 00627755541161 - Lac-Mac: 2024-08-30 Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size L
• 00627755551160 - Lac-Mac: 2024-08-30 Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size XL
• 00627755561169 - Lac-Mac: 2024-08-30 Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size 2XL
• 00627755571168 - Lac-Mac: 2024-08-30 Gown, non-surgical, Level 2, grippers at neck, tie at waist, special color coded neckband, Size 3XL
• 00627755531148 - Lac-Mac: 2024-08-29 Surgical Gown, Level 4, grippers at neck, tie at waist, special color coded neckband, Size M
• 00627755531155 - Lac-Mac: 2024-08-29 Surgical Gown, Level 3, grippers at neck, tie at waist, special color coded neckband, Size M