DemeSORB

GUDID 30652927719216

Absorbable, Synthetic, Polyglycolic acid Suture

DEMETECH CORPORATION

Polyester suture, bioabsorbable, multifilament Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial Polyester suture, bioabsorbable, multifilament, non-antimicrobial
Primary Device ID30652927719216
NIH Device Record Keye1bc7383-af57-46cb-8d75-712b87556ea3
Commercial Distribution StatusIn Commercial Distribution
Brand NameDemeSORB
Version Model NumberPGA282024B4P
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS110652927719212 [Primary]
GS130652927719216 [Package]
Contains: 10652927719212
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-23
Device Publish Date2020-04-15

On-Brand Devices [DemeSORB]

30652927262989Synthetci (Polyglycolic Acid)Absorbable Suture
30652927255318Absorbable, Synthetic, Polyglycolic acid Suture
30652927250474Absorbable, Synthetic, Polyglycolic acid Suture
30652927247979Absorbable, Synthetic, Polyglycolic acid Suture
30652927246651Absorbable, Synthetic, Polyglycolic acid Suture
30652927240789Absorbable, Synthetic, Polyglycolic acid Suture
30652927228329Absorbable, Synthetic, Polyglycolic acid Suture
30652927211284Absorbable, Synthetic, Polyglycolic acid Suture
30652927208819Absorbable, Synthetic, Polyglycolic acid Suture
30652927208802Absorbable, Synthetic, Polyglycolic acid Suture
30652927207744Absorbable, Synthetic, Polyglycolic acid Suture
30652927207737Absorbable, Synthetic, Polyglycolic acid Suture
30652927207683Absorbable, Synthetic, Polyglycolic acid Suture
30652927206884Absorbable, Synthetic, Polyglycolic acid Suture
30652927194228Absorbable, Synthetic, Polyglycolic acid Suture
30652927193702Absorbable, Synthetic, Polyglycolic acid Suture
30652927188708Absorbable, Synthetic, Polyglycolic acid Suture
30652927188258Absorbable, Synthetic, Polyglycolic acid Suture
30652927187466Absorbable, Synthetic, Polyglycolic acid Suture
30652927187459Absorbable, Synthetic, Polyglycolic acid Suture
30652927187442Absorbable, Synthetic, Polyglycolic acid Suture
30652927187398Absorbable, Synthetic, Polyglycolic acid Suture
30652927186636Absorbable, Synthetic, Polyglycolic acid Suture
30652927186629Absorbable, Synthetic, Polyglycolic acid Suture
30652927186452Absorbable, Synthetic, Polyglycolic acid Suture
30652927186254Absorbable, Synthetic, Polyglycolic acid Suture
30652927185783Absorbable, Synthetic, Polyglycolic acid Suture
30652927185448Absorbable, Synthetic, Polyglycolic acid Suture
30652927185400Absorbable, Synthetic, Polyglycolic acid Suture
30652927185301Absorbable, Synthetic, Polyglycolic acid Suture
30652927185295Absorbable, Synthetic, Polyglycolic acid Suture
30652927185288Absorbable, Synthetic, Polyglycolic acid Suture
30652927185233Absorbable, Synthetic, Polyglycolic acid Suture
30652927181358Absorbable, Synthetic, Polyglycolic acid Suture
30652927181334Absorbable, Synthetic, Polyglycolic acid Suture
30652927181310Absorbable, Synthetic, Polyglycolic acid Suture
30652927181303Absorbable, Synthetic, Polyglycolic acid Suture
30652927181143Absorbable, Synthetic, Polyglycolic acid Suture
10652927181095Absorbable, Synthetic, Polyglycolic acid Suture
30652927667586Absorbable, Synthetic, Polyglycolic acid Suture
30652927400718Absorbable, Synthetic, Polyglycolic acid Suture
30652927317986Absorbable, Synthetic, Polyglycolic acid Suture
30652927313803Absorbable, Synthetic, Polyglycolic acid Suture
30652927308427Absorbable, Synthetic, Polyglycolic acid Suture
30652927306133Absorbable, Synthetic, Polyglycolic acid Suture
30652927305716Absorbable, Synthetic, Polyglycolic acid Suture
30652927303835Absorbable, Synthetic, Polyglycolic acid Suture
30652927271868Absorbable, Synthetic, Polyglycolic acid Suture
30652927271301Absorbable, Synthetic, Polyglycolic acid Suture
30652927271288Absorbable, Synthetic, Polyglycolic acid Suture

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