MANI Sutures Polyester 3376

GUDID 04546951400743

MANI Ophthalmic Sutures

MANI, INC.

Polyester suture, non-bioabsorbable, multifilament

Primary Device ID	04546951400743
NIH Device Record Key	9f13dcce-937d-4d45-b178-7d9d9f3dcbde
Commercial Distribution Status	In Commercial Distribution
Brand Name	MANI Sutures Polyester
Version Model Number	3376
Catalog Number	3376
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	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	04546951400743 [Primary]
GS1	14546951400740 [Package] Package: [12 Units] In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K050150

FDA Product Code

GAT	Suture, Nonabsorbable, Synthetic, Polyethylene

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	2016-06-04

On-Brand Devices [MANI Sutures Polyester]

04546951500399	9
04546951500382	8
04546951500337	4
04546951402839	MANI Ophthalmic Sutures
04546951402815	MANI Ophthalmic Sutures
04546951402792	MANI Ophthalmic Sutures
04546951402785	MANI Ophthalmic Sutures
14546951402676	MANI Ophthalmic Sutures
14546951402669	MANI Ophthalmic Sutures
04546951402655	MANI Ophthalmic Sutures
04546951402181	MANI Ophthalmic Sutures
04546951401917	MANI Ophthalmic Sutures
04546951401436	MANI Ophthalmic Sutures
14546951401426	MANI Ophthalmic Sutures
14546951400856	MANI Ophthalmic Sutures
14546951400764	MANI Ophthalmic Sutures
14546951400757	MANI Ophthalmic Sutures
04546951400743	MANI Ophthalmic Sutures
04546951400736	MANI Ophthalmic Sutures
14546951400726	MANI Ophthalmic Sutures
04546951400705	MANI Ophthalmic Sutures
04546951400538	MANI Ophthalmic Sutures