Premium UNIFY Silk Sutures

GUDID 10814639026761

Premium UNIFY Silk Sutures, 5-0, 19mm 3/8 circle Rev Cut, 18". Black.

APPLIED DENTAL, INC.

Silk suture
Primary Device ID10814639026761
NIH Device Record Key67af49e1-8a22-441b-87da-5361486950f9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY Silk Sutures
Version Model NumberPMS-518R19
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
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
GS100814639026764 [Primary]
GS110814639026761 [Package]
Contains: 00814639026764
Package: box [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAPSuture, Nonabsorbable, Silk

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-30
Device Publish Date2025-06-20

On-Brand Devices [Premium UNIFY Silk Sutures]

10814639026792Premium UNIFY Silk Sutures, 6-0, 13mm 3/8 circle Rev Cut, 18". Black.
10814639026785Premium UNIFY Silk Sutures, 5-0, 13mm 3/8 circle Rev Cut, 18". Black.
10814639026778Premium UNIFY Silk Sutures, 4-0, 13mm 3/8 circle Rev Cut, 18". Black.
10814639026761Premium UNIFY Silk Sutures, 5-0, 19mm 3/8 circle Rev Cut, 18". Black.
10814639026754Premium UNIFY Silk Sutures, 4-0, 19mm 3/8 circle Rev Cut, 18". Black.
10814639026747Premium UNIFY Silk Sutures, 3-0, 19mm 3/8 circle Rev Cut, 18". Black.

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