UNIFY PGA Surgical Sutures

GUDID 10814639025511

UNIFY PGA Surgical Sutures, Absorbable, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Primary Device ID10814639025511
NIH Device Record Key27510389-a3f8-43a8-a82e-bcfc12b1f2f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY PGA Surgical Sutures
Version Model NumberXS-G518R11-U
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
GS100814639025514 [Primary]
GS110814639025511 [Package]
Contains: 00814639025514
Package: box [12 Units]
In Commercial Distribution
GS120814639025518 [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 PGA Surgical Sutures]

20814639022890UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18". Undyed.
20814639022883UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Rev Cut, 18"
20814639022876UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18". Undyed.
20814639022869UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Rev Cut, 18"
20814639022562UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Conventional Cut, 18". Undyed.
20814639022555UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Conventional Cut, 18". Undyed.
20814639022548UNIFY PGA Surgical Sutures, Absorbable, 5-0, 16mm 3/8 Circle Conventional Cut, 18"
20814639022531UNIFY PGA Surgical Sutures, Absorbable, 4-0, 16mm 3/8 Circle Conventional Cut, 18"
10814639021650UNIFY PGA Surgical Sutures, Size 8-0, Braided Coated, 6.4mm 3/8 Cir Spatula, Double, 12"
10814639021643UNIFY PGA Surgical Sutures, Size 6-0, Braided Coated, 6.4mm 3/8 Cir Spatula, Double, 12"
10814639021636UNIFY PGA Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30". Violet.
10814639021629UNIFY PGA Surgical Sutures, Absorbable, XS, 7-0, 11mm 3/8 Circle Rev Cut, 18" Violet
10814639021612UNIFY PGA Surgical Sutures, Absorbable, XS, 6-0, 11mm 3/8 Circle Rev Cut, 18" Undyed.
10814639021605UNIFY PGA Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30" Undyed.
10814639021599UNIFY PGA Surgical Sutures, Absorbable, XL 2-0, 36mm 1/2 Circle Taper Pt, 30"
10814639021582UNIFY PGA Surgical Sutures, Absorbable, XL 0, 36mm 1/2 Circle Taper Pt, 30"
10814639021575UNIFY PGA Surgical Sutures, Absorbable, XL 0, 30mm 3/8 Circle Rev Cut, 30"
10814639021131UNIFY PGA Surgical Sutures, Absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
10814639021124UNIFY PGA Surgical Sutures, Absorbable, 6-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021117UNIFY PGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
10814639021100UNIFY PGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021094UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18" Undyed
10814639021087UNIFY PGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021070UNIFY PGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18"
10814639021063UNIFY PGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
10814639021056UNIFY PGA Surgical Sutures, Absorbable, 4-0, 17mm 1/2 Circle Taper Pt, 30". Undyed
10814639021049UNIFY PGA Surgical Sutures, Absorbable, 4-0, 17mm 1/2 Circle Taper Pt, 30"
10814639021032UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 30"
10814639021025UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18" Undyed
10814639021018UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18"
10814639021001UNIFY PGA Surgical Sutures, Absorbable, 3-0, 17mm 1/2 Circle Taper Pt, 30"
10814639020998UNIFY PGA Surgical Sutures,Absorbable, 3-0, 17mm 1/2 Circle Taper Pt, 30". Undyed
10814639020981UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 30"
10814639020974UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18", Undyed
10814639020967UNIFY PGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18"
10814639020950UNIFY PGA Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30". Undyed
10814639020943UNIFY PGA Surgical Sutures, Absorbable, 3-0, 26mm 1/2 Circle Taper Pt, 30"
10814639020936UNIFY PGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 30". Undyed
10814639020929UNIFY PGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 30"
10814639020912UNIFY PGA Surgical Sutures, Absorbable, 2-0, 26mm 1/2 Circle Taper Pt, 30". Undyed
10814639020905UNIFY PGA Surgical Sutures, Absorbable, LG 2-0, 26mm 1/2 Circle Taper Pt, 30"
10814639020899UNIFY PGA Surgical Sutures Absorbable, LG 2-0, 24mm 3/8 Circle Rev Cut, 30"
10814639025511UNIFY PGA Surgical Sutures, Absorbable, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed
10814639025597UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Cir, R/C Violet, 18"3 DZN Pack
30814639025294UNIFY PGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Cir R/C, 18" Undyed 3 DZN Pack

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