MANI Sutures Polyester 8

GUDID 04546951500382

MANI, INC.

Polyester suture, non-bioabsorbable, multifilament
Primary Device ID04546951500382
NIH Device Record Key7531f360-260e-45ce-a03e-004437cecfec
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANI Sutures Polyester
Version Model Number8
Catalog Number8
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
GS104546951500382 [Primary]
GS114546951500389 [Package]
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GATSuture, Nonabsorbable, Synthetic, Polyethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-03-25

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