SFAM Pledget

GUDID 00854804007259

6mm Round Pledget

SURGICAL TECHNOLOGY LABORATORIES INC

PTFE/carbon-fibre craniofacial tissue reconstructive material

• Primary Device ID: 00854804007259
• NIH Device Record Key: 639cc0bf-ddaa-490f-8a73-51579a94a51d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SFAM Pledget
• Version Model Number: PLG-6-RD
• 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	00854804007259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021889

FDA Product Code

• KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-07-23
• Device Publish Date: 2025-07-15

Devices Manufactured by SURGICAL TECHNOLOGY LABORATORIES INC

• 00854804007259 - SFAM Pledget: 2025-07-236mm Round Pledget
• 00854804007259 - SFAM Pledget: 2025-07-23 6mm Round Pledget
• 00854804007129 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Large - Skin Color - 1.6mm
• 00854804007136 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Large - Skin Color - 2.0mm
• 00854804007143 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Large - White Color - 1.6mm
• 00854804007150 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Large - White Color - 2.0mm
• 00854804007167 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Small - Skin Color - 1.6mm
• 00854804007174 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Small - Skin Color - 2.0mm
• 00854804007198 - SurgiPlast Nasal Splint: 2024-10-08 SurgiPlast - Small - White Color - 1.6mm