UNIFY Silk Surgical Sutures

GUDID 20814639023163

UNIFY Silk Sutures, XXL 2-0/30", 60mm Straight Cutting

APPLIED DENTAL, INC.

Silk suture, sterile
Primary Device ID20814639023163
NIH Device Record Key0df8774e-ff45-408d-a3a5-1114498550f8
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY Silk Surgical Sutures
Version Model NumberXXL-S230K60
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
GS100814639023169 [Primary]
GS110814639023166 [Package]
Contains: 00814639023169
Package: box [12 Units]
In Commercial Distribution
GS120814639023163 [Package]
Contains: 10814639023166
Package: Case [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAPSuture, Nonabsorbable, Silk

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-01-01

On-Brand Devices [UNIFY Silk Surgical Sutures]

20814639023163UNIFY Silk Sutures, XXL 2-0/30", 60mm Straight Cutting
20814639023132UNIFY Silk Sutures, XXL 3-0/30", 60mm Straight Cutting
20814639022647Silk, Med 5-0, 16mm 3/8 Circle Rev Cut, 18"
20814639022630Silk, Med 4-0, 16mm 3/8 Circle Rev Cut, 18"
10814639020677Silk, Small 6-0 13mm 3/8 Circle Rev Cut, 18"
10814639020660Silk, Small 5-0 13mm 3/8 Circle Rev Cut, 18"
10814639020653Silk, Small 4-0, 13mm 3/8 Circle Rev Cut, 18"
10814639020646Silk, Med 5-0, 19mm 3/8 Circle Rev Cut, 18"
10814639020639Silk, Med 4-0/30", 19mm 3/8 Circle Rev Cut
10814639020622Silk, Med 4-0, 19mm 3/8 Circle Rev Cut, 18"
10814639020615Silk, Med 3-0/30", 19mm 3/8 Circle Rev Cut
10814639020608Silk, Med 3-0, 19mm 3/8 Circle Rev Cut, 18"
10814639020295UNIFY Silk Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30"

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