FILAPRON PCL30497U

GUDID 18904255203263

Monofilament Poly (glycolide-co-caprolactone) Surgical Suture

MERIL ENDO SURGERY PRIVATE LIMITED

Poliglecaprone suture
Primary Device ID18904255203263
NIH Device Record Keye91a41e4-8c58-4dd9-888d-9ed9a6060fc7
Commercial Distribution StatusIn Commercial Distribution
Brand NameFILAPRON
Version Model NumberPCL30497U
Catalog NumberPCL30497U
Company DUNS870914838
Company NameMERIL ENDO SURGERY PRIVATE LIMITED
Device Count12
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

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

Device Identifiers

Device Issuing AgencyDevice ID
GS108904255203266 [Unit of Use]
GS118904255203263 [Primary]

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 Date2018-12-07
Device Publish Date2018-11-06

On-Brand Devices [FILAPRON]

18904255222776Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255220000Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255219998Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255219929Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255219875Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255219868Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255219844Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255218342Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255218090Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255218069Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255218007Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255217413Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255216973Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255216768Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255215204Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255214931Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255213989Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255213927Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255213194Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255212883Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255209470Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255208077Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255207858Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255207841Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255206882Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255206752Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255206523Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255203263Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255203232Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
18904255202822Monofilament Poly (glycolide-co-caprolactone) Surgical Suture
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