Model: M-Y497G
DI: 20612479283002
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-20
Current Version: 2026-05-28
Description
SUTURE, MONOFIL 3-0 18" UD
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
c32b493c-f0dd-42a5-92c8-41fceb54ece3
Distribution Status:
In Commercial Distribution
DUNS Number:
023904428
Device Count:
12
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
Yes
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
40612479284409
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
24
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
20612479283002
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
20612479283002
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Device ID:
10612479283593
Item #3 - Device ID Type:
Unit of Use
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 16584
Name: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Definition:
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.
FDA Product Codes
GAM
Suture, Absorbable, Synthetic, Polyglycolic Acid
Premarket Submissions
Submission Number:
K172659
Supplement Number:
000