FILAXYN PDX60117DNZ

GUDID 18904255222752

Monofilament poly (p-dioxanone) Surgical Suture

MERIL ENDO SURGERY PRIVATE LIMITED

Polyester suture, bioabsorbable, monofilament Polyester suture, bioabsorbable, monofilament 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 ID: 18904255222752
• NIH Device Record Key: d792e276-7d2c-46a7-98ae-50a95a911e60
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FILAXYN
• Version Model Number: PDX60117DNZ
• Catalog Number: PDX60117DNZ
• Company DUNS: 870914838
• Company Name: MERIL ENDO SURGERY PRIVATE LIMITED
• Device Count: 36
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com
• Phone: +1(609)9512287
• Email: asksutures@merillife.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C
• Special Storage Condition, Specify: Between 0 and 0 *Store below 25 °C

Device Identifiers

Device Issuing Agency	Device ID
GS1	08904255222755 [Unit of Use]
GS1	18904255222752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K172659

FDA Product Code

• NEW: Suture, Surgical, Absorbable, Polydioxanone

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-02-07
• Device Publish Date: 2018-11-06

On-Brand Devices [FILAXYN]

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