DemeLENE

GUDID 30652927683692

Synthetic, Monofilament , Nonabsorbable Suture

DEMETECH CORPORATION

Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament Polyolefin/fluoropolymer suture, monofilament
Primary Device ID30652927683692
NIH Device Record Key89f84262-fc7a-465e-b16e-12ced8da0df2
Commercial Distribution StatusIn Commercial Distribution
Brand NameDemeLENE
Version Model NumberPM2113030F4P
Company DUNS039436691
Company NameDEMETECH CORPORATION
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us
Phone3058241048
Emailinfo@demetech.us

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS110652927683698 [Primary]
GS130652927683692 [Package]
Contains: 10652927683698
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAWSuture, Nonabsorbable, Synthetic, Polypropylene

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-01-22
Device Publish Date2020-01-14

On-Brand Devices [DemeLENE]

30652927256216Synthetic (Polypropylene), Non Absorbable Suture
30652927224697Synthetic (polypropylene), Non Absorbable Suture
30652927214797Synthetic, Monofilament , Nonabsorbable Suture
30652927202848Synthetic (Polypropylene), Absorbable Suture
30652927201339Synthetic, Monofilament , Nonabsorbable Suture
30652927201094Synthetic, Monofilament , Nonabsorbable Suture
10652927200871Synthetic, Monofilament , Nonabsorbable Suture
10652927200864Synthetic, Monofilament , Nonabsorbable Suture
30652927198134Synthetic, Monofilament , Nonabsorbable Suture
30652927197496Synthetic, Monofilament , Nonabsorbable Suture
30652927196444Synthetic, Monofilament , Nonabsorbable Suture
30652927196437Synthetic, Monofilament , Nonabsorbable Suture
30652927196246Synthetic, Monofilament , Nonabsorbable Suture
30652927196239Synthetic, Monofilament , Nonabsorbable Suture
30652927195386Synthetic, Monofilament , Nonabsorbable Suture
30652927195379Synthetic, Monofilament , Nonabsorbable Suture
30652927193566Synthetic, Monofilament , Nonabsorbable Suture
30652927193474Synthetic, Monofilament , Nonabsorbable Suture
30652927186643Synthetic, Monofilament , Nonabsorbable Suture
30652927181419Synthetic, Monofilament , Nonabsorbable Suture
30652927181396Synthetic, Monofilament , Nonabsorbable Suture
30652927668170Synthetic (polypropylene), Non Absorbable Suture
30652927432849Synthetic (polypropylene), Non Absorbable Suture
30652927432832Synthetic (polypropylene), Non Absorbable Suture
30652927431712Synthetic (polypropylene), Non Absorbable Suture
30652927428217Synthetic (polypropylene), Non Absorbable Suture
30652927427302Synthetic (polypropylene), Non Absorbable Suture
30652927414586Synthetic (polypropylene), Non Absorbable Suture
30652927412469Synthetic (polypropylene), Non Absorbable Suture
30652927397452Synthetic (polypropylene), Non Absorbable Suture
30652927396042Synthetic (polypropylene), Non Absorbable Suture
30652927395656Synthetic (polypropylene), Non Absorbable Suture
30652927394451Synthetic (polypropylene), Non Absorbable Suture
30652927393744Synthetic (polypropylene), Non Absorbable Suture
30652927393416Synthetic (polypropylene), Non Absorbable Suture
30652927379311Synthetic (polypropylene), Non Absorbable Suture
30652927367943Synthetic (polypropylene), Non Absorbable Suture
30652927357401Synthetic (polypropylene), Non Absorbable Suture
30652927337106Synthetic (polypropylene), Non Absorbable Suture
30652927325394Synthetic (polypropylene), Non Absorbable Suture
30652927325370Synthetic (polypropylene), Non Absorbable Suture
30652927325301Synthetic (polypropylene), Non Absorbable Suture
30652927324250Synthetic (polypropylene), Non Absorbable Suture
30652927322287Synthetic (polypropylene), Non Absorbable Suture
30652927322133Synthetic (polypropylene), Non Absorbable Suture
30652927320535Synthetic (polypropylene), Non Absorbable Suture
30652927320023Synthetic (polypropylene), Non Absorbable Suture
30652927320016Synthetic (polypropylene), Non Absorbable Suture
30652927319119Synthetic (polypropylene), Non Absorbable Suture
30652927318921Synthetic (polypropylene), Non Absorbable Suture

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