Pureform 1ML02

GUDID 00850987007048

1ML02 PureForm - ePTFE Malar Implant - Small

SURGICAL TECHNOLOGY LABORATORIES INC

Malar prosthesis

• Primary Device ID: 00850987007048
• NIH Device Record Key: e72b9acb-db66-4f01-afc9-20c69a394c57
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pureform
• Version Model Number: 1ML02
• Catalog Number: 1ML02
• Company DUNS: 080380106
• Company Name: SURGICAL TECHNOLOGY LABORATORIES 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: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850987007048 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091011

FDA Product Code

• LZK: Implant, Malar

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Pureform]

• 00850987007307: "7AND02 Asian Nasal Dorsum - Curved"
• 00850987007291: "7AND01 Asian Nasal Dorsum - Curved"
• 00850987007284: "6AND02 Asian Nasal Dorsum - Straight"
• 00850987007277: "6AND01 Asian Nasal Dorsum - Curved"
• 00850987007260: "5AND02 Asian Nasal Dorsum - Straight"
• 00850987007253: "5AND01 Asian Nasal Dorsum - Curved"
• 00850987007246: "6PN01 Para-Nasal - Large"
• 00850987007239: "5PN01 Para-Nasal - Medium"
• 00850987007222: "4PN01 PureForm Para-Nasal - Small"
• 00850987007215: "6NDSR Round Top Nasal Dorsum"
• 00850987007208: "5NDSR Round Top Nasal Dorsum"
• 00850987007192: "4NDSR Round Top Nasal Dorsum"
• 00850987007185: "4AND04 Asian Nasal Dorsum - Straight"
• 00850987007178: "4AND03 Asian Nasal Dorsum - Straight"
• 00850987007161: "4AND02 Asian Nasal Dorsum - Curved"
• 00850987007154: "4AND01 Asian Nasal Dorsum - Curved"
• 00850987007147: "3NDR02 3mm Rounded Nasal Dorsum - Large"
• 00850987007130: "3NDR01 3mm Rounded Nasal Dorsum - Small"
• 00850987007123: "3NDP02 3mm Pointed Nasal Dorsum - Large"
• 00850987007116: "3NDP01 3mm Pointed Nasal Dorsum -Small"
• 00850987007109: "2NDR02 2mm Rounded Nasal Dorsum - Large"
• 00850987007093: "2NDR01 2mm Rounded Nasal Dorsum - Small"
• 00850987007086: "2NDP02 2mm Pointed Nasal Dorsum - Large"
• 00850987007079: "2NDP01 PureForm 2mm Pointed Nasal Dorsum - Small"
• 00850987007062: "1ML04 PureForm - ePTFE Malar - Large"
• 00850987007055: "1ML03 PureForm - ePTFE Malar - Medium"
• 00850987007048: 1ML02 PureForm - ePTFE Malar Implant - Small
• 00850987007031: 1ML02 PureForm - ePTFE Malar Implant - Small
• 00850987007024: 1EC03 - Large ePTFE Chin Implant Copy Copy
• 00850987007017: 1EC02 - Medium ePTFE Chin Implant Copy
• 00850987007000: 1EC01 - Small ePTFE Chin Implant
• 00854804007082: "5PN01* PureForm Para-Nasal - Medium Left"
• 00854804007075: "4PN01* PureForm Para-Nasal - Small Left"
• 00854804007068: "6PN01* PureForm Para-Nasal - Large Left"