Premium UNIFY PDO Sutures

GUDID 20814639022692

Premium UNIFY PDO Sutures, Sm 4-0, 13mm 3/8 circle Rev Cut, 18"

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, monofilament
Primary Device ID20814639022692
NIH Device Record Key48f78236-33dc-426e-84c9-36fa3ab834c9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY PDO Sutures
Version Model NumberPSD-418R13
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639022698 [Primary]
GS110814639022695 [Package]
Contains: 00814639022698
Package: box [12 Units]
In Commercial Distribution
GS120814639022692 [Package]
Contains: 10814639022695
Package: case [100 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 Number5
Public Version Date2019-02-07
Device Publish Date2016-11-03

On-Brand Devices [Premium UNIFY PDO Sutures]

20814639023842Premium PDO, Med 3-0, 19mm 3/8 Cir Rev Cut, Violet, 18"
20814639023835Premium PDO Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
20814639023774Premium PDO Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
20814639022715Premium UNIFY PDO Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18"
20814639022708Premium UNIFY PDO Sutures, Sm 5-0, 13mm 3/8 circle Rev Cut, 18"
20814639022692Premium UNIFY PDO Sutures, Sm 4-0, 13mm 3/8 circle Rev Cut, 18"
20814639022685Premium UNIFY PDO Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
20814639022678Premium UNIFY PDO Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18"
20814639022661Premium UNIFY PDO Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18"
20814639022654Premium UNIFY PDO Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18"
10814639023272Premium PDO, Med 2-0, 19mm 3/8 Cir Rev Cut, Violet, 18"
10814639025993Premium PDO, Med 4-0, 19mm 3/8 Cir Rev Cut, Violet, 27"
10814639025986Premium PDO, Med 3-0, 19mm 3/8 Cir Rev Cut, Violet, 27"
10814639025979Premium PDO, Med 2-0, 19mm 3/8 Cir Rev Cut, Violet, 27"
10814639025962Premium PDO Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, Violet, 27"

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