DemeSORB

GUDID 10652927259909

Absorbable, Synthetic, Polyglycolic acid Suture

DEMETECH TRADING CORPORATION

Polyester suture, bioabsorbable, multifilament
Primary Device ID10652927259909
NIH Device Record Key9f5ab743-2126-4135-826f-7707ba23893c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDemeSORB
Version Model NumberPGA282026H0P
Company DUNS039436691
Company NameDEMETECH TRADING 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

Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
Emailinfo@demetech.us
Phone305-824-1048
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
GS110652927259909 [Primary]
GS130652927259903 [Package]
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 Date2019-06-03
Device Publish Date2019-05-24

Devices Manufactured by DEMETECH TRADING CORPORATION

30652927197373 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
30652927197441 - DemeGUT2019-06-12 Plain Gut, Sterile, Absorbable Surgical Suture
30652927206938 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
30652927213042 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
30652927214940 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
30652927214957 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
30652927222167 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
30652927222174 - DemeGUT2019-06-12 Chromic Gut, Sterile, Absorbable Surgical Suture
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.