Premium UNIFY PGA Sutures

GUDID 20814639022722

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

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament
Primary Device ID20814639022722
NIH Device Record Key1ccb0f32-7a51-466a-b8c3-b3d541ee96f8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY PGA Sutures
Version Model NumberPMG-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 Latextrue
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
GS100814639022728 [Primary]
GS110814639022725 [Package]
Contains: 00814639022728
Package: box [12 Units]
In Commercial Distribution
GS120814639022722 [Package]
Contains: 10814639022725
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 Number4
Public Version Date2019-07-15
Device Publish Date2016-11-04

On-Brand Devices [Premium UNIFY PGA Sutures]

40814639023037Premium UNIFY PGA Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
20814639022753Premium UNIFY PGA Sutures, Med 5-0, 16mm 3/8 Circle Rev Cut, 18". Undyed.
20814639022746Premium UNIFY PGA Sutures, Med 4-0, 16mm 3/8 Circle Rev Cut, 18" Undyed.
40814639022733Premium UNIFY PGA Sutures, Med 5-0, 16mm 3/8 Circle Rev Cut, 18"
20814639022722Premium UNIFY PGA Sutures, Med 4-0, 16mm 3/8 Circle Rev Cut, 18"
10814639021568Premium UNIFY PGA Sutures, XL 2-0, 36mm 1/2 Cir Taper point, 27" Undyed.
10814639021551Premium UNIFY PGA Sutures, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021544Premium UNIFY PGA Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021537Premium UNIFY PGA Sutures, Med 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021520Premium UNIFY PGA Sutures, Med 4-0, 19mm 3/8 Circle Rev Cut, 18"
10814639021513Premium UNIFY PGA Sutures, L 3-0, 26mm 1/2 Cir Taper point, Undyed, 27"
10814639021506Premium UNIFY PGA Sutures, L 3-0, 26mm 1/2 Cir Taper point, Undyed, 18"
10814639021490Premium UNIFY PGA Sutures, L 3-0, 26mm 1/2 Cir Taper point, 27"
20814639024955Premium UNIFY PGA Sutures, Sm 4-0, 13mm 3/8 Circle Rev Cut, 18" Violet.
20814639024948Premium UNIFY PGA Sutures, Sm 5-0, 13mm 3/8 Circle Rev Cut, 18" Violet.
00814639025552Premium PGA Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, unyded, 27"
10814639026051Premium UNIFY PGA Sutures, Med 4-0, 19mm 3/8 Circle Rev Cut, 27" Undyed.
10814639026044Premium UNIFY PGA Sutures, Med 4-0, 19mm 3/8 Circle Rev Cut, 27" Violet.
10814639026037Premium UNIFY PGA Sutures, Med 5-0, 19mm 3/8 Circle Rev Cut, 18". Undyed.
10814639026020Premium UNIFY PGA Sutures, Med 5-0, 19mm 3/8 Circle Rev Cut, 18" Violet.
10814639026013Premium UNIFY PGA Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 18" Violet.
10814639026006Premium PGA Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, undyed, 27"
10814639023753Premium PGA Suture, Size 2-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
10814639026716Premium UNIFY PGA Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 27" Undyed.
10814639026709Premium UNIFY PGA Sutures, Med 3-0, 19mm 3/8 Circle Rev Cut, 27" Violet.
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