FDA UDI
In Commercial Distribution
🇺🇸 United States
FILAXYN
DI: 18904255209692
·
Model: PDX01347Z
·
MERIL ENDO SURGERY PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
36
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Basic Information
- Brand Name
- FILAXYN
- Primary DI
- 18904255209692
- Version / Model
- PDX01347Z
- Catalog Number
- PDX01347Z
- Company Name
- MERIL ENDO SURGERY PRIVATE LIMITED
- Labeler DUNS
- 870914838
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 36
- Record Status
- Published
- Publish Date
- 2018-10-05
- Public Version
- 4
- Public Version Date
- 2021-02-05
- Public Version Status
- Update
- Public Device Record Key
- fc2db02e-56e5-457e-9843-228c76f62219
Device Description
Monofilament poly (p-dioxanone) Surgical Suture
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NEW | Suture, Surgical, Absorbable, Polydioxanone | General, Plastic Surgery | 878.4840 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 16584 | Polyester suture, bioabsorbable, monofilament, non-antimicrobial | A single-strand (monofilament), synthetic, bioabsorbable thread made from a polyester (e.g., polydioxanone, poliglecaprone, polycaprolactone, polyglyconate, polyhydroxybutyrate) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 18904255209692 | GS1 | ||||
| Unit of Use | 08904255209695 | GS1 |
Customer Contacts
- Phone
- +1(609)9512287
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K172659 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store below 25 °C