Surgiform TM-04

GUDID 00851988007815

"TM-04 Trapezoidal Malar Silicone Implants"

SURGICAL TECHNOLOGY LABORATORIES INC

Malar prosthesis

• Primary Device ID: 00851988007815
• NIH Device Record Key: 06dc3422-2d43-4492-abee-f4fb67ce1848
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgiform
• Version Model Number: TM-04
• Catalog Number: TM-04
• 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	00851988007815 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K983756

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 [Surgiform]

• 00851988007976: SB-6MF Silicone Block - Size Three - Med Duro - Flesh Tone
• 00851988007969: SB-6MC Silicone Block - Size Six - Med Duro-Clear
• 00851988007952: SB-6SF Silicone Block - Size Six -Soft -Flesh Tone
• 00851988007945: SB-6SC Silicone Block - Size Six - Soft -Clear
• 00851988007938: "SB-3MF Silicone Block - Size Three - Med Duro - Flesh Tone"
• 00851988007921: "SB-3SF Silicone Block - Size Three -Soft -Flesh Tone"
• 00851988007914: "SB-3SC Silicone Block - Size Three - Soft -Clear"
• 00851988007907: "SB-03 Silicone Block - Size Three - Med Duro-Clear"
• 00851988007891: "SB-2MF Silicone Block - Size Two - Med Duro -Flesh Tone"
• 00851988007884: "SB-2SF Silicone Block - Size Two - Soft -Flesh Tone Silicone Implants"
• 00851988007877: "SB-2SC Silicone Block - Size Two - Soft -Clear"
• 00851988007860: "SB-02 Silicone Block - Size Two - Med Duro - Clear"
• 00851988007853: "SB-1MF Silicone Block - Size One - Med Duro -Flesh Tone Silicone Implants"
• 00851988007846: "SB-1SC Silicone Block - Size One - Soft -Clear Silicone Implants"
• 00851988007839: "SB-1SF Silicone Block - Size One - Soft -Flesh Tone Silicone Implants"
• 00851988007822: "SB-01 Silicone Block - Size One - Med Duro - Clear Silicone Implants"
• 00851988007815: "TM-04 Trapezoidal Malar Silicone Implants"
• 00851988007808: "TM-03 Trapezoidal Malar Silicone Implants"
• 00851988007792: "TM-02 Trapezoidal Malar Silicone Implants"
• 00851988007785: "TM-01 Trapezoidal Malar Silicone Implants"
• 00851988007778: "SM-06 Standard Malar Silicone Implants"
• 00851988007761: "SM-05 Standard Malar Silicone Implants"
• 00851988007754: "SM-04 Standard Malar Silicone Implants"
• 00851988007747: "SM-03 Standard Malar Silicone Implants"
• 00851988007730: "SM-02 Standard Malar Silicone Implants"
• 00851988007723: "SM-01 Standard Malar Silicone Implants"
• 00851988007716: "SC-06 Standard Chin - Size 6 Silicone Implants"
• 00851988007709: "SC-05 Standard Chin Silicone Implants"
• 00851988007693: "SC-04 Standard Chin Silicone Implants"
• 00851988007686: "SC-03 Standard Chin Silicone Implants"
• 00851988007679: "SC-02 Standard Chin Silicone Implants"
• 00851988007662: "SC-01 Standard Chin Silicone Implants"
• 00851988007655: "OFD2-03 Ofodile Series II Silicone Implants"
• 00851988007648: "OFD2-02 Ofodile Series II Silicone Implants"
• 00851988007631: "OFD2-01 Ofodile Series II Silicone Implants"
• 00851988007624: "OFD1-03 Ofodile Series I Silicone Implants"
• 00851988007617: "OFD1-02 Ofodile Series I Silicone Implants"
• 00851988007600: "OFD1-01 Ofodile Series I Silicone Implants"
• 00851988007594: "ND-14C Nasal Dorsal Series C Silicone Implants"
• 00851988007587: "ND-13C Nasal Dorsal Series C Silicone Implants"
• 00851988007570: "ND-12C Nasal Dorsal Series C Silicone Implants"
• 00851988007563: "ND-11C Nasal Dorsal Series C Silicone Implants"
• 00851988007556: "ND-10B Nasal Dorsal Series B Silicone Implants"
• 00851988007549: "ND-09B Nasal Dorsal Series B Silicone Implants"
• 00851988007532: "ND-08B Nasal Dorsal Series B Silicone Implants"
• 00851988007525: "ND-07B Nasal Dorsal Series B Silicone Implants"
• 00851988007518: "ND-06B Nasal Dorsal Implant Silicone Implants"
• 00851988007501: "ND-05A Nasal Dorsal Series A Silicone Implants"
• 00851988007495: "ND-05 Nasal Dorsal - Size 05 Silicone Implants"
• 00851988007488: "ND-04A Nasal Dorsal Series A Silicone Implants"