AccessGUDID - DEVICE: FILAXYN (18904255222738)

GUDID

Device Identifier (DI) Information

Brand Name: FILAXYN
Version or Model: PDX60127DNZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PDX60127DNZ
Company Name: MERIL ENDO SURGERY PRIVATE LIMITED

Primary DI Number: 18904255222738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 36
Labeler D-U-N-S® Number*: 870914838 *Terms of Use

Device Description: Monofilament poly (p-dioxanone) Surgical Suture

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NEW	Suture, Surgical, Absorbable, Polydioxanone

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K172659	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store below 25 °C

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: efd76f30-52bb-49cc-a410-94fb88d4e20f
Public Version Date: February 05, 2021
Public Version Number: 4
DI Record Publish Date: November 06, 2018