Premium UNIFY Chromic Sutures

GUDID 10814639022787

Premium UNIFY Chromic Sutures Med 4-0, 16mm 3/8 Circle Rev Cut, 18"

APPLIED DENTAL, INC.

Catgut suture, chromic
Primary Device ID10814639022787
NIH Device Record Keycc729eb1-5da6-48cf-8ff5-d727a8a46a34
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY Chromic Sutures
Version Model NumberPMC-418R16
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
GS100814639022780 [Primary]
GS110814639022787 [Package]
Contains: 00814639022780
Package: box [50 Units]
In Commercial Distribution
GS120814639022784 [Package]
Contains: 00814639022780
Package: case [1200 Units]
In Commercial Distribution
GS130814639022781 [Package]
Contains: 00814639022780
Package: box [12 Units]
In Commercial Distribution
GS140814639022788 [Package]
Contains: 30814639022781
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 StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [Premium UNIFY Chromic Sutures]

10814639022916Premium UNIFY Plain Gut Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 27"
10814639022909Premium UNIFY Chromic Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 27"
10814639022794Premium UNIFY Chromic Sutures Med 5-0, 16mm 3/8 Circle Rev Cut, 18"
10814639022787Premium UNIFY Chromic Sutures Med 4-0, 16mm 3/8 Circle Rev Cut, 18"
10814639022770Premium UNIFY Plain Gut Sutures Med 5-0, 16mm 3/8 Circle Rev Cut, 18"
10814639022763Premium UNIFY Plain Gut Sutures Med 4-0, 16mm 3/8 Circle Rev Cut, 18"
10814639022459Premium UNIFY Chromic Sutures, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18"
10814639022442Premium UNIFY Chromic Sutures Med 3-0, 19mm 3/8 Circle Rev Cut, 18"
10814639021384Premium UNIFY Chromic Sutures, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021377Premium UNIFY Chromic Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021360Premium UNIFY Chromic Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 18"
10814639021353Premium UNIFY Chromic Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 27"
10814639021346Premium UNIFY Chromic Sutures, LG 2-0, 26mm 1/2 Cir Taper point, 27"
10814639021339Premium UNIFY Chromic Sutures, XL 2-0, 36mm 1/2 Cir Taper point, 27"
10814639021322Premium UNIFY Chromic Sutures, LG 2-0, 24mm 3/8 Circle Rev Cut, 27"
10814639024828Premium UNIFY Chromic Sutures, LG 3-0, 24mm 3/8 Circle Rev Cut, 27"

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