MANI Sutures Silk 34

GUDID 04546951500276

MANI, INC.

Silk suture, sterile
Primary Device ID04546951500276
NIH Device Record Keyb86db54d-d397-4c3f-b5ab-68190f89c005
Commercial Distribution StatusIn Commercial Distribution
Brand NameMANI Sutures Silk
Version Model Number34
Catalog Number34
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
GS104546951500276 [Primary]
GS114546951500273 [Package]
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAPSuture, Nonabsorbable, Silk

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 Date2016-03-25

On-Brand Devices [MANI Sutures Silk]

0454695152255127L
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0454695150019127
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0454695150012220
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0454695150001610
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04546951402747MANI Ophthalmic Sutures
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04546951402587MANI Ophthalmic Sutures
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04546951402532MANI Ophthalmic Sutures
04546951402488MANI Ophthalmic Sutures
04546951402358MANI Ophthalmic Sutures
04546951402235MANI Ophthalmic Sutures
04546951402228MANI Ophthalmic Sutures
04546951402044MANI Ophthalmic Sutures
04546951402037MANI Ophthalmic Sutures
04546951401979MANI Ophthalmic Sutures
04546951401948MANI Ophthalmic Sutures
04546951401931MANI Ophthalmic Sutures
04546951401924MANI Ophthalmic Sutures
04546951401900MANI Ophthalmic Sutures

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