DemeCAPRONE

GUDID 30652927722117

Synthetic (Poligecaprone 25) Absorbable 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 ID30652927722117
NIH Device Record Key516e5dcc-63a0-4630-b7c4-c61b0564c3f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameDemeCAPRONE
Version Model NumberMO3x1830
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 Numbertrue
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
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS110652927722113 [Primary]
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution
GS130652927722117 [Package]
Contains: 10652927722113
Package: [12 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
GAMSuture, Absorbable, Synthetic, Polyglycolic Acid
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 Date2020-10-16
Device Publish Date2020-10-08

On-Brand Devices [DemeCAPRONE]

30652927287418Synthetic (Poligecaprone 25) Absorbable Suture
30652927244244Synthetic (Poliglecaprone 25), Absorbable Suture
30652927668446Synthetic (Poliglecaprone 25), Absorbable Suture
30652927668064Synthetic (Poliglecaprone 25), Absorbable Suture
30652927667678Synthetic (Poliglecaprone 25), Absorbable Suture
10652927667407Synthetic (Poliglecaprone 25), Absorbable Suture
30652927432382Synthetic (Poliglecaprone 25), Absorbable Suture
30652927428361Synthetic (Poliglecaprone 25), Absorbable Suture
30652927427333Synthetic (Poliglecaprone 25), Absorbable Suture
30652927414371Synthetic (Poliglecaprone 25), Absorbable Suture
30652927414326Synthetic (Poliglecaprone 25), Absorbable Suture
30652927414272Synthetic (Poliglecaprone 25), Absorbable Suture
30652927414265Synthetic (Poliglecaprone 25), Absorbable Suture
30652927402439Synthetic (Poliglecaprone 25), Absorbable Suture
30652927402040Synthetic (Poliglecaprone 25), Absorbable Suture
30652927402019Synthetic (Poliglecaprone 25), Absorbable Suture
30652927396127Synthetic (Poliglecaprone 25), Absorbable Suture
30652927395977Synthetic (Poliglecaprone 25), Absorbable Suture
30652927395960Synthetic (Poliglecaprone 25), Absorbable Suture
30652927395779Synthetic (Poliglecaprone 25), Absorbable Suture
30652927393546Synthetic (Poliglecaprone 25), Absorbable Suture
30652927393409Synthetic (Poliglecaprone 25), Absorbable Suture
30652927389617Synthetic (Poliglecaprone 25), Absorbable Suture
30652927389556Synthetic (Poliglecaprone 25), Absorbable Suture
30652927379175Synthetic (Poliglecaprone 25), Absorbable Suture
30652927378901Synthetic (Poliglecaprone 25), Absorbable Suture
30652927368278Synthetic (Poliglecaprone 25), Absorbable Suture
30652927368261Synthetic (Poliglecaprone 25), Absorbable Suture
30652927368223Synthetic (Poliglecaprone 25), Absorbable Suture
30652927368179Synthetic (Poliglecaprone 25), Absorbable Suture
30652927368162Synthetic (Poliglecaprone 25), Absorbable Suture
30652927367950Synthetic (Poliglecaprone 25), Absorbable Suture
30652927367769Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357746Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357739Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357722Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357715Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357708Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357692Synthetic (Poliglecaprone 25), Absorbable Suture
30652927357142Synthetic (Poliglecaprone 25), Absorbable Suture
10652927347002Synthetic (Poliglecaprone 25), Absorbable Suture
30652927346993Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326988Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326971Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326964Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326957Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326940Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326933Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326926Synthetic (Poliglecaprone 25), Absorbable Suture
30652927326919Synthetic (Poliglecaprone 25), Absorbable Suture

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