FILAXYN PDX50320DNZ
GUDID 18904255218021
Monofilament poly (p-dioxanone) Surgical Suture
MERIL ENDO SURGERY PRIVATE LIMITED
Polyester suture, bioabsorbable, monofilament| Primary Device ID | 18904255218021 |
| NIH Device Record Key | e9f68034-85be-4dff-8223-5404c489684e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | FILAXYN |
| Version Model Number | PDX50320DNZ |
| Catalog Number | PDX50320DNZ |
| 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 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| asksutures@merillife.com | |
| Phone | +1(609)9512287 |
| 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 | 08904255218024 [Unit of Use] |
| GS1 | 18904255218021 [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 |
Trademark Results [FILAXYN]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FILAXYN 86757953 not registered Dead/Abandoned |
Meril Endo Surgery Private Limited 2015-09-16 |
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