MANI Sutures PGA 1490

GUDID 14546951403666

MANI Ophthalmic Sutures

MANI, INC.

Polyglycolic acid suture
Primary Device ID14546951403666
NIH Device Record Keyf8ea2ff1-0d64-4a53-be9d-880c4f8bfbfc
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANI Sutures PGA
Version Model Number1490
Catalog Number1490
Company DUNS690622428
Company NameMANI, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS104546951403669 [Primary]
GS114546951403666 [Package]
Contains: 04546951403669
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-09
Device Publish Date2016-06-15

On-Brand Devices [MANI Sutures PGA]

04546951525514503
04546951525507502
04546951525491501
04546951525484404
04546951525477403
04546951525460402
04546951525453401
04546951525446303
04546951525439302
04546951525422301
14546951404366MANI Ophthalmic Sutures
14546951403833MANI Ophthalmic Sutures
14546951403802MANI Ophthalmic Sutures
14546951403666MANI Ophthalmic Sutures
04546951403201MANI Ophthalmic Sutures
04546951403195MANI Ophthalmic Sutures
04546951403188MANI Ophthalmic Sutures
04546951403171MANI Ophthalmic Sutures
04546951403164MANI Ophthalmic Sutures
04546951403140MANI Ophthalmic Sutures

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