UNIFY PP Surgical Sutures

GUDID 20814639022586

Polypropylene, Non-absorbable 5-0, 16mm 3/8 Cir Rev Cut, 18" Dyed.

APPLIED DENTAL, INC.

Polyolefin suture, monofilament
Primary Device ID20814639022586
NIH Device Record Key27f9e1c4-558f-4041-87c7-59ee7b5a124d
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY PP Surgical Sutures
Version Model NumberM-P518R16
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
GS100814639022582 [Primary]
GS110814639022589 [Package]
Contains: 00814639022582
Package: box [12 Units]
In Commercial Distribution
GS120814639022586 [Package]
Contains: 10814639022589
Package: case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-11-10

On-Brand Devices [UNIFY PP Surgical Sutures]

20814639023347Polypropylene Suture, Non-absorbable, Size 2/0, 24mm Reverse Cut Needle, 30".
20814639023316Polypropylene Suture, Non-absorbable, Size 0, 36mm Taper Point Needle, 30".
20814639023286Polypropylene Suture, Non-absorbable, Size 2, 40mm Taper Point Needle, 30".
20814639023224Polypropylene Suture, Non-absorbable 2/0,60mm Straight Cutting needle, 30".
20814639022586Polypropylene, Non-absorbable 5-0, 16mm 3/8 Cir Rev Cut, 18" Dyed.
20814639022579Polypropylene, Nonbsorbable 4-0, 16mm 3/8 Cir Rev Cut, 18" Dyed.
10814639021940Polypropylene, Nonbsorbable 7-0, 11mm 3/8 Cir Rev Cut, 18" Blue.
10814639021933Polypropylene, Nonbsorbable 6-0, 11mm 3/8 Cir Rev Cut, 18" Blue.
10814639021926Polypropylene, Nonbsorbable 6-0, 13mm 3/8 Cir Rev Cut, 18" Blue.
10814639021919Polypropylene, Nonbsorbable 5-0, 13mm 3/8 Cir Rev Cut, 18" Blue.
10814639021902Polypropylene, Nonbsorbable 4-0, 13mm 3/8 Cir Rev Cut, 18" Blue.
10814639021896Polypropylene, Nonbsorbable 5-0,19mm 3/8 Cir Rev Cut, 18" Blue.
10814639021889Polypropylene, Nonabsorbable 4-0,19mm 3/8 Cir Rev Cut, 30" Blue.
10814639021872Polypropylene, Nonbsorbable 4-0, 19mm 3/8 Cir Rev Cut, 18" Blue.
10814639021865Polypropylene, Nonabsorbable 3-0,19mm 3/8 Cir Rev Cut, 30" Blue.
10814639021858Polypropylene, Nonabsorbable 3-0, 19mm 3/8 Cir Rev Cut, 18" Blue.
10814639025894Polypropylene, Nonabsorbable 6-0, 13mm 3/8 Cir Rev Cut, 18" Blue.3 DZN
10814639025887Polypropylene, Nonabsorbable 5-0, 13mm 3/8 Cir Rev Cut, 18" Blue. 3 Dzn.
10814639025870Polypropylene, Nonabsorbable 4-0, 13mm 3/8 Cir Rev Cut, 18" Blue. 3 Dzn
10814639025863Polypropylene, Nonabsorbable 4-0, 19mm 3/8 Cir Rev Cut, 18" Blue. 3 dzn.

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