L-553B

GUDID 00841336100909

SALVIN 3-0 Gut Plain C7 Needle 27"(70cm) Bx 12

Salvin Dental Specialties, Inc.

Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain Catgut suture, plain

• Primary Device ID: 00841336100909
• NIH Device Record Key: 2fb35fae-9b2c-4ae2-be0a-855a2e4e9b00
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: L-553B
• Version Model Number: L-553B
• 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	00841336100909 [Primary]
GS1	10841336100906 [Package]; 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-22
• Device Publish Date: 2020-01-14

Devices Manufactured by Salvin Dental Specialties, Inc.

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• 00841336103146 - Replacement Mallet Cap (Set of 2): 2023-08-28
• 00841336103054 - #5 Front Surface Cone Socket Mirror - Box of 12: 2023-08-24
• 00841336102675 - Flexible Stainless Steel Surgical Ruler - 6" (15.25cm): 2023-08-21
• 00841336101128 - Salvin Adson Tissue Forcep-Curved-Serrated 4 3/4": 2023-08-18
• 00841336101135 - Salvin Adson Titanium Curved Tissue Forceps 12cm: 2023-08-18
• 00841336101142 - Salvin Bayonet Elevator Offset "In" - Small: 2023-08-18
• 00841336101159 - Salvin Debakey Atraumatic Tissue Forcep Straight: 2023-08-18