L-589B

GUDID 10841336100562

SALVIN 4-0 CHROMIC GUT T4(SH-1) NEEDLE 14"(35CM)

Salvin Dental Specialties, Inc.

Catgut suture, chromic

• Primary Device ID: 10841336100562
• NIH Device Record Key: 31aac053-945a-469b-aca7-2d7b30b6662d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-589B
• Version Model Number: L-589B
• 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	00841336100565 [Primary]
GS1	10841336100562 [Package]; Contains: 00841336100565; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K896554

FDA Product Code

• GAL: Suture, Absorbable, Natural

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-10-30

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• 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