Premium UNIFY Nylon Sutures

GUDID 20814639023712

Premium UNIFY Nylon Sutures, LG 3-0, 24mm 3/8 circle Rev Cut, 27"

APPLIED DENTAL, INC.

Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament Nylon suture, non-bioabsorbable, monofilament
Primary Device ID20814639023712
NIH Device Record Key2a824ca7-84e1-4e06-b6e4-defff2215aeb
Commercial Distribution StatusIn Commercial Distribution
Brand NamePremium UNIFY Nylon Sutures
Version Model NumberPLN-327R24
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100814639023718 [Primary]
GS110814639023715 [Package]
Contains: 00814639023718
Package: box [12 Units]
In Commercial Distribution
GS120814639023712 [Package]
Contains: 10814639023715
Package: case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GARSuture, Nonabsorbable, Synthetic, Polyamide

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-08-13

On-Brand Devices [Premium UNIFY Nylon Sutures]

20814639023729Premium UNIFY Nylon Sutures, LG 4-0, 24mm 3/8 circle Rev Cut, 27"
20814639023712Premium UNIFY Nylon Sutures, LG 3-0, 24mm 3/8 circle Rev Cut, 27"
20814639023705Premium UNIFY Nylon Sutures, LG 2-0, 24mm 3/8 circle Rev Cut, 27"
20814639023583Premium UNIFY Nylon Sutures, Sm 6-0, 13mm 3/8 circle Rev Cut, 18", Undyed
20814639023576Premium UNIFY Nylon Sutures, Sm 5-0, 13mm 3/8 circle Rev Cut, 18", Undyed
20814639023569Premium UNIFY Nylon Sutures, Sm 4-0, 13mm 3/8 circle Rev Cut, 18", Undyed
20814639023552Premium UNIFY Nylon Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18", Undyed
20814639023545Premium UNIFY Nylon Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18", Undyed
20814639023538Premium UNIFY Nylon Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18", Undyed
20814639023521Premium UNIFY Nylon Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18", Undyed
20814639023514Premium UNIFY Nylon Sutures, Medium 3-0, 19mm 3/8 circle Rev Cut, 18", Undyed
20814639022845Premium UNIFY Nylon Sutures, Med 5-0, 16mm 3/8 circle Rev Cut, 18"
20814639022838Premium UNIFY Nylon Sutures, Med 4-0, 16mm 3/8 circle Rev Cut, 18"
10814639021483Premium UNIFY Nylon Sutures, Small 6-0, 13mm 3/8 circle Rev Cut, 18"
10814639021476Premium UNIFY Nylon Sutures, Small 5-0, 13mm 3/8 circle Rev Cut, 18"
10814639021469Premium UNIFY Nylon Sutures, Small 4-0, 13mm 3/8 circle Rev Cut, 18"
10814639021452Premium UNIFY Nylon Sutures, Med 5-0, 19mm 3/8 circle Rev Cut, 18"
10814639021445Premium UNIFY Nylon Sutures, Med 4-0, 19mm 3/8 circle Rev Cut, 18"
10814639021438Premium UNIFY Nylon Sutures, 3-0, 19mm 3/8 circle Rev Cut, 18"
10814639025955Premium UNIFY Nylon Sutures, 4-0, 19mm 3/8 circle Rev Cut, 27", Black.
10814639025948Premium UNIFY Nylon Sutures, 3-0, 19mm 3/8 circle Rev Cut, 27", Black.
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