Premium UNIFY RPGA Surgical Sutures

GUDID 10814639024439

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

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Primary Device ID10814639024439
NIH Device Record Key929843ea-45cf-413e-9920-8dd03bf62ae9
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY RPGA Surgical Sutures
Version Model NumberPSK-518R13
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
GS100814639024432 [Primary]
GS110814639024439 [Package]
Contains: 00814639024432
Package: Box [12 Units]
In Commercial Distribution
GS120814639024436 [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 [Premium UNIFY RPGA Surgical Sutures]

10814639024835Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 24mm 3/8 Circle Rev Cut, 27". Undyed
10814639024439Premium UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 13mm 3/8 Circle Rev Cut, 18". Undyed
10814639024422Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 13mm 3/8 Circle Rev Cut, 18". Undyed
10814639024415Premium UNIFY RPGA Surgical Sutures, Absorbable, 5-0, 19mm 3/8 Circle Rev Cut, 18". Undyed
10814639024408Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 27". Undyed
10814639024392Premium UNIFY RPGA Surgical Sutures, Absorbable, 4-0, 19mm 3/8 Circle Rev Cut, 18". Undyed
10814639024385Premium UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 24mm 3/8 Circle Rev Cut, 27". Undyed
10814639024378Premium UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 18". Undyed
00814639024364Premium UNIFY RPGA Surgical Sutures, Absorbable, 3-0, 19mm 3/8 Circle Rev Cut, 27". Undyed

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