UNIFY Silk Surgical Sutures

GUDID 10814639020295

UNIFY Silk Surgical Sutures, XXL 1, 40mm 3/8 circle Rev Cut, 30"

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 ID10814639020295
NIH Device Record Keyf1d99f60-8431-4132-af48-7adc92c75e57
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY Silk Surgical Sutures
Version Model NumberXXL-1N30R40
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 Numbertrue
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
GS100814639020298 [Primary]
GS110814639020295 [Package]
Contains: 00814639020298
Package: box [12 Units]
In Commercial Distribution
GS120814639020292 [Package]
Package: case [100 Units]
In Commercial Distribution

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 Number3
Public Version Date2019-02-07
Device Publish Date2015-08-19

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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