Premium UNIFY PGCL Surgical Sutures

GUDID 20814639022968

Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, monofilament
Primary Device ID20814639022968
NIH Device Record Keye76f80b9-dc2a-45b4-9b02-986e9286ddc4
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY PGCL Surgical Sutures
Version Model NumberPMQ-318R19
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
GS100814639022964 [Primary]
GS110814639022961 [Package]
Contains: 00814639022964
Package: box [12 Units]
In Commercial Distribution
GS120814639022968 [Package]
Contains: 10814639022961
Package: case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-07-12
Device Publish Date2016-11-09

On-Brand Devices [Premium UNIFY PGCL Surgical Sutures]

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20814639023002Premium PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
20814639022999Premium PGCL, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
20814639022982Premium PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
20814639022975Premium PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
20814639022968Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
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10814639025283Premium PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
10814639025276Premium PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
10814639024460Premium PGCL, Absorbable, Sm, 4-0, 13mm 3/8 Circle Rev Cut, 18" Violet Color
10814639026112Premium PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
10814639026105Premium PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 27" Undyed.
10814639026099Premium PGCL, LG 4-0, 24mm 3/8 Circle Rev Cut, 27". Undyed.
10814639026082Premium PGCL, LG 3-0, 24mm 3/8 Circle Rev Cut, 27". Undyed.
10814639026075Premium PGCL, LG 2-0, 24mm 3/8 Circle Rev Cut, 27". Undyed.
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