UNIFY Plain Gut Sutures

GUDID 10814639021247

UNIFY Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18"

APPLIED DENTAL, INC.

Catgut suture, plain
Primary Device ID10814639021247
NIH Device Record Key9367ab0a-d5e3-4662-9840-ad76a4b18e13
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY Plain Gut Sutures
Version Model NumberS-J518R13
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
GS100814639021240 [Primary]
GS110814639021247 [Package]
Contains: 00814639021240
Package: box [12 Units]
In Commercial Distribution

FDA Product Code

GALSuture, Absorbable, Natural

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-08-21

On-Brand Devices [UNIFY Plain Gut Sutures]

10814639021247UNIFY Plain Gut Sutures, Small 5-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021230UNIFY Plain Gut Sutures, Small 4-0, 13mm 3/8 Circle Rev Cut, 18"
10814639021223UNIFY Plain Gut Sutures
10814639021216UNIFY Plain Gut Sutures Med 3-0, 19mm 3/8 Circle Rev Cut, 27"
10814639026693UNIFY Plain Gut Sutures, 5-0, 19mm 3/8 Circle Rev Cut, 18"
10814639026679UNIFY Plain Gut Sutures, 5-0, 16mm 3/8 Circle Rev Cut, 18"
10814639026662UNIFY Plain Gut Sutures Med 4-0, 19mm 3/8 Circle Rev Cut, 30"
10814639026655UNIFY Plain Gut Sutures, 4-0, 16mm 3/8 Circle Rev Cut, 18"
10814639026648UNIFY Plain Gut Sutures, 3-0, 19mm 3/8 Circle Rev Cut, 18"
10814639026617UNIFY Plain Gut Sutures, Small 6-0, 13mm 3/8 Circle Rev Cut, 18"

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.