AccessGUDID - DEVICE: FILAPRON (18904255222776)

GUDID

Device Identifier (DI) Information

Brand Name: FILAPRON
Version or Model: PCL30523UZ
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PCL30523UZ
Company Name: MERIL ENDO SURGERY PRIVATE LIMITED

Primary DI Number: 18904255222776
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 36
Labeler D-U-N-S® Number*: 870914838 *Terms of Use

Device Description: Monofilament Poly (glycolide-co-caprolactone) 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?
45814	Poliglecaprone suture	A sterile, single-strand (monofilament), synthetic, bioabsorbable thread made of poliglecaprone (a copolymer of glycolide and E-caprolactone of low tissue reactivity) intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached needle intended to be disposed of after single use. The thread provides temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid

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: 86b7de63-e3ee-460d-b728-c6e3ac32548a
Public Version Date: December 07, 2018
Public Version Number: 1
DI Record Publish Date: November 06, 2018