SINUSORB® PGA

GUDID 13661522022129

PETERS SURGICAL

Polyester suture, bioabsorbable, multifilament
Primary Device ID13661522022129
NIH Device Record Keya9fff051-0234-47f0-8daa-f62e71728103
Commercial Distribution StatusIn Commercial Distribution
Brand NameSINUSORB® PGA
Version Model Number8120
Company DUNS265741780
Company NamePETERS SURGICAL
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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
GS103661522022122 [Primary]
GS113661522022129 [Package]
Contains: 03661522022122
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-17
Device Publish Date2020-01-09

On-Brand Devices [SINUSORB® PGA]

136615220221058107
136615220149648114
136615220149578113
136615220149028106
136615220148968104
136615220292418146
136615220282828144
136615220272788143
136615220250698142
136615220231028135
136615220229768140
136615220229698139
136615220229528138
136615220229458134
136615220228778136
136615220227098137
136615220221298120
136615220221128108
136615220151078133
136615220150918132
136615220150848131
136615220150778130
136615220150608129
136615220150538128
136615220150468127
136615220150398126
136615220150228125
136615220150158124
136615220150088123
136615220149958121
136615220149888118
136615220149718117
136615220149408112
136615220149338111
136615220149268110
136615220149198109
136615220148898102
136615220148728101

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