L-592B

GUDID 10841336100616

SALVIN 3-0 GUT PLAIN C6(FS-2) NEEDLE 18"(45CM)

Salvin Dental Specialties, Inc.

Catgut suture, plain

• Primary Device ID: 10841336100616
• NIH Device Record Key: afae3f64-0cb0-49a5-a8e4-f76bade5348b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-592B
• Version Model Number: L-592B
• 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	00841336100619 [Primary]
GS1	10841336100616 [Package]; Contains: 00841336100619; 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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• 00841336111998 - SALVINOSS-B: 2024-06-04 SalvinOss®B Bovine Xenograft Bone Graft Material - 0.25 cc 250-1000 microns