MANI Sutures PGA 402

GUDID 04546951525460

MANI, INC.

Polyglycolic acid suture
Primary Device ID04546951525460
NIH Device Record Key37b18884-80ca-4015-afce-8c6210352335
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANI Sutures PGA
Version Model Number402
Catalog Number402
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104546951525460 [Primary]

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 Number4
Public Version Date2018-07-09
Device Publish Date2016-03-25

On-Brand Devices [MANI Sutures PGA]

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04546951525446303
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04546951525422301
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04546951403195MANI Ophthalmic Sutures
04546951403188MANI Ophthalmic Sutures
04546951403171MANI Ophthalmic Sutures
04546951403164MANI Ophthalmic Sutures
04546951403140MANI Ophthalmic Sutures

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