ORAMEM-15X20

GUDID 00841336100824

Salvin OraMem Absorbable Collagen Membrane 15x20mm

Salvin Dental Specialties, Inc.

Dental soft-tissue matrix implant, animal-derived

• Primary Device ID: 00841336100824
• NIH Device Record Key: ccb82c2f-c5cb-46ce-8a7b-7abf018c3a49
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ORAMEM-15X20
• Version Model Number: REV7/08
• Company DUNS: 113344790
• Company Name: Salvin Dental Specialties, 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: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841336100824 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924408

FDA Product Code

• LYC: Bone Grafting Material, Synthetic

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: 2020-03-09
• Device Publish Date: 2020-02-28

Devices Manufactured by Salvin Dental Specialties, Inc.

• 00841336112032 - Salvin: 2024-06-10 Salvin OraMEM® Plus Resorbable Collagen Membrane - 15x20mm
• 00841336112049 - Salvin: 2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 20x30mm
• 00841336112056 - Salvin: 2024-06-07 Salvin OraMEM® Plus Resorbable Collagen Membrane - 30x40mm
• 00841336111929 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material -0.25g (0.54cc) 250-1000 microns
• 00841336111936 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.5g (1.08cc) 250-1000 microns
• 00841336111943 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 1.0g (2.16cc) 250-1000 microns
• 00841336111950 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 2.0g(4.32cc) 250-1000 microns
• 00841336111998 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns