MANI Sutures PGA 3393

GUDID 14546951404366

MANI Ophthalmic Sutures

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	14546951404366
NIH Device Record Key	276977bb-cd26-4373-94e3-299b2ff486ae
Commercial Distribution Status	In Commercial Distribution
Brand Name	MANI Sutures PGA
Version Model Number	3393
Catalog Number	3393
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	04546951404369 [Primary]
GS1	14546951404366 [Package] Contains: 04546951404369 Package: [12 Units] In Commercial Distribution

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	2016-12-06

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
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14546951403802	MANI Ophthalmic Sutures
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04546951403201	MANI Ophthalmic Sutures
04546951403195	MANI Ophthalmic Sutures
04546951403188	MANI Ophthalmic Sutures
04546951403171	MANI Ophthalmic Sutures
04546951403164	MANI Ophthalmic Sutures
04546951403140	MANI Ophthalmic Sutures