Premium UNIFY PGLA Sutures

GUDID 20814639023798

Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.

APPLIED DENTAL, INC.

Polyester suture, bioabsorbable, multifilament
Primary Device ID20814639023798
NIH Device Record Keyb95a0ad0-7576-4178-971c-9050f299b534
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY PGLA Sutures
Version Model NumberPSGU-618R13
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
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
GS100814639023794 [Primary]
GS110814639023791 [Package]
Contains: 00814639023794
Package: box [12 Units]
In Commercial Distribution
GS120814639023798 [Package]
Contains: 10814639023791
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 Number2
Public Version Date2019-07-15
Device Publish Date2018-08-13

On-Brand Devices [Premium UNIFY PGLA Sutures]

10814639023920Premium PGLA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Undyed, 27"
10814639023913Premium PGLA Suture, Size 2/0, 40mm 1/2 Cir Taper Point, Violet, 27"
10814639023906Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Undyed, 27"
10814639023890Premium PGLA Suture, Size 0, 40mm 1/2 Cir Taper Point, Violet, 27"
10814639023883Premium PGLA Suture, Size 1, 40mm 1/2 Cir Taper Point, Undyed. 27"
20814639023804Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Violet.
20814639023798Premium PGLA, Sm 6-0, 13mm 3/8 Circle Rev Cut, 18" Undyed.
20814639023781Premium PGLA Suture, Size 4-0, 24mm 3/8 Cir Rev Cut, Violet, 27"
20814639023767Premium PGLA Suture, Size 3-0, 24mm 3/8 Cir Rev Cut, Violet, 27"

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