PDM

GUDID 00812444021103

SUTURE

RIVERPOINT MEDICAL, LLC

Polyester suture, bioabsorbable, monofilament
Primary Device ID00812444021103
NIH Device Record Keya97c46bd-697b-46db-9c2f-5eaee253e5d8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePDM
Version Model NumberD970
Company DUNS964053560
Company NameRIVERPOINT MEDICAL, LLC
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 Datefalse
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
GS100812444021103 [Primary]
GS110812444021100 [Package]
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEWSuture, Surgical, Absorbable, Polydioxanone

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 Date2015-10-16

On-Brand Devices [PDM]

00812444021103SUTURE
00812444021097SUTURE
00812444021080SUTURE
00812444021073SUTURE
00812444021066SUTURE
00812444021059SUTURE
00812444021042SUTURE
00812444021035SUTURE
00812444021011SUTURE
00812444021004SUTURE
00812444020991SUTURE
00812444020984SUTURE
00812444020977SUTURE
00812444020960SUTURE
00812444020953SUTURE
00812444020946SUTURE
00812444020939SUTURE
00812444020922SUTURE
00812444020915SUTURE
00812444020908SUTURE
00812444020892SUTURE
00812444020885SUTURE
10812444029298Suture
10812444021025Suture
10810020084723Suture
10810020084716Suture
10810020084709Suture
10810020084693Suture
10840277405828Suture

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