UNIFY PTFE Surgical Sutures

GUDID 10814639024859

PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30"

APPLIED DENTAL, INC.

Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyester suture, non-bioabsorbable, monofilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament Polyolefin/fluoropolymer suture, multifilament
Primary Device ID10814639024859
NIH Device Record Key2e37feb6-ec42-4f71-8ae7-92ed8e7aa14b
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIFY PTFE Surgical Sutures
Version Model NumberXXL-F330K50
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
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
GS100814639024852 [Primary]
GS110814639024859 [Package]
Contains: 00814639024852
Package: Box [12 Units]
In Commercial Distribution
GS120814639024856 [Package]
Package: Carton [100 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NBYSuture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-08-14
Device Publish Date2020-08-06

On-Brand Devices [UNIFY PTFE Surgical Sutures]

20814639023699PTFE Sutures, Non-absorbable, 6-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
20814639023682PTFE Sutures, Non-absorbable, 5-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
20814639023675PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 1/2 circle Taper Point, 18"
20814639023668PTFE Sutures, Non-absorbable, 4-0, monofilament, 13mm 3/8 circle Rev Cut, 18"
20814639023651PTFE Sutures, Non-absorbable, 4-0, monofilament, 19mm 3/8 circle Rev Cut, 18"
20814639023644PTFE Sutures, Non-absorbable, 4-0, monofilament, 16mm 3/8 circle Rev Cut, 18"
20814639023637PTFE Sutures, Non-absorbable, 3-0, monofilament, 16mm 3/8 circle Rev Cut, 18"
20814639023620PTFE Sutures, Non-absorbable, 3-0, monofilament, 19mm 3/8 circle Rev Cut, 18"
00814639023619PTFE Sutures, Non-absorbable, 2-0, monofilament, 19mm 3/8 circle Rev Cut, 18"
10814639024859PTFE Sutures, Non-absorbable, 3-0, monofilament, 50mm straight needle, 30"
10814639024842PTFE Sutures, Non-absorbable, 2-0, monofilament, 60mm straight needle, 30"
10814639024057PTFE Sutures, Non-absorbable, 2-0, monofilament, 36mm 1/2 circle Taper point, 30"
10814639022237PTFE Sutures, Non-absorbable, 5-0, monofilament, 16mm 3/8 circle Rev Cut, 18"
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