DemeDIOX

GUDID 30652927719650

Absorbable Polydioxanone Surgical Suture

DEMETECH CORPORATION

Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Primary Device ID30652927719650
NIH Device Record Keyb2b1db1b-c698-45df-aaf6-39f484c7143b
Commercial Distribution StatusIn Commercial Distribution
Brand NameDemeDIOX
Version Model NumberPX184016F12M
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS110652927719656 [Primary]
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution
GS130652927719650 [Package]
Contains: 10652927719656
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone
NEWSuture, Surgical, Absorbable, Polydioxanone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [DemeDIOX]

30652927413688Absorbable Polydioxanone Surgical Suture
30652927257602Absorbable Polydioxanone Surgical Suture
30652927250566Absorbable Polydioxanone Surgical Suture
30652927250559Absorbable Polydioxanone Surgical Suture
30652927241687Absorbable Polydioxanone Surgical Suture
30652927241557Absorbable Polydioxanone Surgical Suture
30652927231305Absorbable Polydioxanone Surgical Suture
30652927222280Absorbable Polydioxanone Surgical Suture
30652927215800Absorbable Polydioxanone Surgical Suture
30652927214643Absorbable Polydioxanone Surgical Suture
30652927214063Absorbable Polydioxanone Surgical Suture
30652927208826Absorbable Polydioxanone Surgical Suture
30652927201858Absorbable Polydioxanone Surgical Suture
30652927199216Synthetic (Polydioxanone), Absorbabble Suture
30652927198073Absorbable Polydioxanone Surgical Suture
30652927187695Absorbable Polydioxanone Surgical Suture
30652927187688Absorbable Polydioxanone Surgical Suture
30652927187671Absorbable Polydioxanone Surgical Suture
30652927187664Absorbable Polydioxanone Surgical Suture
30652927185905Absorbable Polydioxanone Surgical Suture
30652927185899Absorbable Polydioxanone Surgical Suture
30652927185882Absorbable Polydioxanone Surgical Suture
30652927185875Absorbable Polydioxanone Surgical Suture
30652927668989Absorbable Polydioxanone Surgical Suture
30652927668262Absorbable Polydioxanone Surgical Suture
30652927668255Absorbable Polydioxanone Surgical Suture
30652927668248Absorbable Polydioxanone Surgical Suture
30652927668231Absorbable Polydioxanone Surgical Suture
30652927668224Absorbable Polydioxanone Surgical Suture
30652927667760Absorbable Polydioxanone Surgical Suture
30652927667746Absorbable Polydioxanone Surgical Suture
30652927667739Absorbable Polydioxanone Surgical Suture
30652927667722Absorbable Polydioxanone Surgical Suture
30652927667685Absorbable Polydioxanone Surgical Suture
30652927667616Absorbable Polydioxanone Surgical Suture
30652927667593Absorbable Polydioxanone Surgical Suture
30652927667456Absorbable Polydioxanone Surgical Suture
30652927432900Absorbable Polydioxanone Surgical Suture
30652927432856Absorbable Polydioxanone Surgical Suture
30652927432825Absorbable Polydioxanone Surgical Suture
30652927432818Absorbable Polydioxanone Surgical Suture
30652927432320Absorbable Polydioxanone Surgical Suture
30652927432313Absorbable Polydioxanone Surgical Suture
30652927432306Absorbable Polydioxanone Surgical Suture
30652927432290Absorbable Polydioxanone Surgical Suture
30652927431033Absorbable Polydioxanone Surgical Suture
30652927430913Absorbable Polydioxanone Surgical Suture
30652927430906Absorbable Polydioxanone Surgical Suture
30652927430890Absorbable Polydioxanone Surgical Suture
30652927430883Absorbable Polydioxanone Surgical Suture

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