UNIFY RPGA Surgical Sutures

GUDID 10814639024927

UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Violet

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 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 ID10814639024927
NIH Device Record Key749b247b-47c8-48d1-99a7-fdb0e3e5b8bf
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY RPGA Surgical Sutures
Version Model NumberS-K518R13-C
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
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
GS100814639024920 [Primary]
GS110814639024927 [Package]
Contains: 00814639024920
Package: Box [12 Units]
In Commercial Distribution
GS120814639024924 [Package]
Package: Carton [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 Date2020-08-12
Device Publish Date2020-08-04

On-Brand Devices [UNIFY RPGA Surgical Sutures]

10814639024927UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Violet
10814639024910UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18". Violet
10814639024903UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 30". Violet
10814639024897UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 30". Violet
10814639024354UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 30". Undyed
10814639024347UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18". Undyed
10814639024330UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 30". Undyed
30814639022217UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Undyed
10814639022206UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18". Undyed
10814639022190UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18". Undyed
10814639022183UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18". Undyed
10814639022176UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 30". Undyed
10814639025528UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 11mm 3/8 Circle Rev Cut, 18" Undyed
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