FILAXYN PDX10370Y

GUDID 18904255213248

Monofilament poly (p-dioxanone) Surgical Suture

MERIL ENDO SURGERY PRIVATE LIMITED

Polyester suture, bioabsorbable, monofilament
Primary Device ID18904255213248
NIH Device Record Keycccbe5bd-c3d0-4ad8-8773-185252951f56
Commercial Distribution StatusIn Commercial Distribution
Brand NameFILAXYN
Version Model NumberPDX10370Y
Catalog NumberPDX10370Y
Company DUNS870914838
Company NameMERIL ENDO SURGERY PRIVATE LIMITED
Device Count24
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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

Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com
Phone+1(609)9512287
Emailasksutures@merillife.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C
Special Storage Condition, SpecifyBetween 0 and 0 *Store below 25 °C

Device Identifiers

Device Issuing AgencyDevice ID
GS108904255213241 [Unit of Use]
GS118904255213248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NEWSuture, Surgical, Absorbable, Polydioxanone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-02-07
Device Publish Date2018-10-05

On-Brand Devices [FILAXYN]

18906070905681Monofilament poly (p-dioxanone) Surgical Suture
18906070904776Monofilament poly (p-dioxanone) Surgical Suture
18904255222752Monofilament poly (p-dioxanone) Surgical Suture
18904255222745Monofilament poly (p-dioxanone) Surgical Suture
18904255222738Monofilament poly (p-dioxanone) Surgical Suture
18904255220376Monofilament poly (p-dioxanone) Surgical Suture
18904255219950Monofilament poly (p-dioxanone) Surgical Suture
18904255218021Monofilament poly (p-dioxanone) Surgical Suture
18904255218014Monofilament poly (p-dioxanone) Surgical Suture
18904255217987Monofilament poly (p-dioxanone) Surgical Suture
18904255216614Monofilament poly (p-dioxanone) Surgical Suture
18904255216355Monofilament poly (p-dioxanone) Surgical Suture
18904255215952Monofilament poly (p-dioxanone) Surgical Suture
18904255215938Monofilament poly (p-dioxanone) Surgical Suture
18904255215181Monofilament poly (p-dioxanone) Surgical Suture
18904255215174Monofilament poly (p-dioxanone) Surgical Suture
18904255215136Monofilament poly (p-dioxanone) Surgical Suture
18904255214962Monofilament poly (p-dioxanone) Surgical Suture
18904255214139Monofilament poly (p-dioxanone) Surgical Suture
18904255213361Monofilament poly (p-dioxanone) Surgical Suture
18904255213248Monofilament poly (p-dioxanone) Surgical Suture
18904255213088Monofilament poly (p-dioxanone) Surgical Suture
18904255209692Monofilament poly (p-dioxanone) Surgical Suture
18904255209685Monofilament poly (p-dioxanone) Surgical Suture
18904255208664Monofilament poly (p-dioxanone) Surgical Suture
18904255208282Monofilament poly (p-dioxanone) Surgical Suture
18904255206820Monofilament poly (p-dioxanone) Surgical Suture
18904255206813Monofilament poly (p-dioxanone) Surgical Suture
18904255206714Monofilament poly (p-dioxanone) Surgical Suture
18904255206691Monofilament poly (p-dioxanone) Surgical Suture
18904255206431Monofilament poly (p-dioxanone) Surgical Suture
18904255206424Monofilament poly (p-dioxanone) Surgical Suture

Trademark Results [FILAXYN]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FILAXYN
FILAXYN
86757953 not registered Dead/Abandoned
Meril Endo Surgery Private Limited
2015-09-16

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