UNIFY PGCL Surgical Sutures

GUDID 10814639025535

PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed.

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID10814639025535
NIH Device Record Key92ffb00b-8d58-4730-ab29-c39285d573c5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY PGCL Surgical Sutures
Version Model NumberXS-Q518R11
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639025538 [Primary]
GS110814639025535 [Package]
Contains: 00814639025538
Package: Box [12 Units]
In Commercial Distribution
GS120814639025532 [Package]
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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-03
Device Publish Date2021-04-23

On-Brand Devices [UNIFY PGCL Surgical Sutures]

20814639022500PGCL, Absorbable, Med, 5-0, 16mm 3/8 Circle, Conventional Cut, 18" Undyed.
20814639022494PGCL, Absorbable, Med, 4-0, 16mm 3/8 Circle, Conventional Cut, 18" Undyed.
10814639022404PGCL Suture, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color.
10814639022343PGCL Suture, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color.
10814639022336PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Violet Color
10814639022312PGCL Sutures, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet Color.
10814639021841PGCL, Absorbable, Size 1, 40mm 1/2 Circle Taper Pt, 30" Undyed.
10814639021834PGCL, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" Undyed.
10814639021827PGCL, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30" Undyed.
10814639021810PGCL, Absorbable, Sm, 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021803PGCL, Absorbable, Sm, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
00814639021783PGCL, Absorbable, Med, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021773PGCL, Absorbable, Med, 4-0, 17mm 1/2 Circle Taper Point, 30" Undyed.
10814639021766PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.
10814639021759PGCL, Absorbable, Med, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021742PGCL, Absorbable, Med, 3-0, 17mm 1/2 Circle Taper Point, 30"
10814639021735PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 30" Undyed.
10814639021728PGCL, Absorbable, Med, 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021711PGCL, Absorbable, LG 3-0, 26mm 1/2 Circle Taper Pt, 30" Undyed.
10814639021704PGCL, Absorbable, LG 3-0, 24mm 3/8 Circle Rev Cut, 30" Undyed.
10814639021698PGCL, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30" Undyed.
10814639021681PGCL, LG 2-0, 24mm 3/8 Circle Rev Cut, 30" Unded.
10814639025542PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18" Violet
10814639025535PGCL, Absorbable, XS, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed.

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