MANI Sutures Nylon 13

GUDID 04546951500047

MANI, INC.

Nylon suture, non-bioabsorbable, monofilament

• Primary Device ID: 04546951500047
• NIH Device Record Key: e0bdc3f2-bca8-4ff7-88cc-164b45bb526f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MANI Sutures Nylon
• Version Model Number: 13
• Catalog Number: 13
• 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	04546951500047 [Primary]
GS1	14546951500044 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053637

FDA Product Code

• GAR: Suture, Nonabsorbable, Synthetic, Polyamide

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-02-07
• Device Publish Date: 2016-03-25

On-Brand Devices [MANI Sutures Nylon]

• 04546951500375: 7
• 04546951500344: 40
• 04546951500320: 39
• 04546951500313: 38
• 04546951500290: 36
• 04546951500283: 35
• 04546951500269: 33
• 04546951500252: 32
• 04546951500245: 31
• 04546951500153: 23
• 04546951500139: 21
• 04546951500108: 19
• 04546951500092: 18
• 04546951500078: 16
• 04546951500061: 15
• 04546951500047: 13
• 04546951500030: 12
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