L-557B

GUDID 00841336100459

SALVIN 5-0 CHROMIC GUT FS-2 NEEDLE 27" (70CM)

Salvin Dental Specialties, Inc.

Catgut suture, chromic

• Primary Device ID: 00841336100459
• NIH Device Record Key: 15cd73a6-cd4c-46e7-ae4b-83387889df6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-557B
• Version Model Number: L-557B
• 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	00841336100459 [Primary]

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: 2018-02-22

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