Premium UNIFY Nylon Sutures

GUDID 20814639023583

Premium UNIFY Nylon Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18", Undyed

APPLIED DENTAL, INC.

Nylon suture, non-bioabsorbable, monofilament
Primary Device ID20814639023583
NIH Device Record Key74ad236e-09a1-4df7-a753-5197cfbf9d0c
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY Nylon Sutures
Version Model NumberPSNU-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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639023589 [Primary]
GS110814639023586 [Package]
Contains: 00814639023589
Package: box [12 Units]
In Commercial Distribution
GS120814639023583 [Package]
Contains: 10814639023586
Package: case [100 Units]
In Commercial Distribution

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-02-07
Device Publish Date2017-07-27

On-Brand Devices [Premium UNIFY Nylon Sutures]

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20814639023705Premium UNIFY Nylon Sutures, LG 2-0, 24mm 3/8 circle Rev Cut, 27"
20814639023583Premium UNIFY Nylon Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18", Undyed
20814639023576Premium UNIFY Nylon Sutures, Sm 5-0, 13mm 3/8 circle Rev Cut, 18", Undyed
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