Premium UNIFY Fast Plain Gut Sutures PSRJ-618R13

GUDID 10814639026495

Premium UNIFY Fast Absorbing Gut Sutures, Small 6-0, 13mm 3/8 Circle Rev Cut, 18"

APPLIED DENTAL, INC.

Catgut suture, plain
Primary Device ID10814639026495
NIH Device Record Keya9406c9e-6003-47b8-858d-d350bbb460ed
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY Fast Plain Gut Sutures
Version Model NumberPSRJ-618R13
Catalog NumberPSRJ-618R13
Company DUNS017524666
Company NameAPPLIED DENTAL, 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

Customer Support Contacts

Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com
Phone1-888-841-8481
Emailinfo.usa@AD-Surgical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639026498 [Primary]
GS110814639026495 [Package]
Contains: 00814639026498
Package: bx [12 Units]
In Commercial Distribution
GS120814639026492 [Package]
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GALSuture, Absorbable, Natural

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-25
Device Publish Date2024-10-17

On-Brand Devices [Premium UNIFY Fast Plain Gut Sutures]

10814639026488Premium UNIFY Fast Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Conventional Cut, 18"
10814639026211Premium UNIFY Fast Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18"
10814639026495Premium UNIFY Fast Absorbing Gut Sutures, Small 6-0, 13mm 3/8 Circle Rev Cut, 18"

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