MANI Sutures PGA 403

GUDID 04546951525477

MANI, INC.

Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture Polyglycolic acid suture

• Primary Device ID: 04546951525477
• NIH Device Record Key: 874d223c-3c0f-402e-968d-291919a14210
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANI Sutures PGA
• Version Model Number: 403
• Catalog Number: 403
• Company DUNS: 690622428
• Company Name: MANI, 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: true
• 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	04546951525477 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053636

FDA Product Code

• GAM: Suture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-09
• Device Publish Date: 2016-03-25

On-Brand Devices [MANI Sutures PGA]

• 04546951525514: 503
• 04546951525507: 502
• 04546951525491: 501
• 04546951525484: 404
• 04546951525477: 403
• 04546951525460: 402
• 04546951525453: 401
• 04546951525446: 303
• 04546951525439: 302
• 04546951525422: 301
• 14546951404366: MANI Ophthalmic Sutures
• 14546951403833: MANI Ophthalmic Sutures
• 14546951403802: MANI Ophthalmic Sutures
• 14546951403666: MANI Ophthalmic Sutures
• 04546951403201: MANI Ophthalmic Sutures
• 04546951403195: MANI Ophthalmic Sutures
• 04546951403188: MANI Ophthalmic Sutures
• 04546951403171: MANI Ophthalmic Sutures
• 04546951403164: MANI Ophthalmic Sutures
• 04546951403140: MANI Ophthalmic Sutures