Model: Y47T
Catalog: Y47T
DI: 10705031471795
Status: New
MRI: MR Safe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-08
Current Version: 2026-05-18
Description
MONOCRYL (poliglecaprone 25) Suture
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
70bd5893-9262-4d3b-b354-e9f4f622d824
Distribution Status:
In Commercial Distribution
DUNS Number:
079402290
Device Count:
1
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:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
BOX
Item #1 - Device ID:
30705031471799
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
24
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10705031471795
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10705031471795
Item #2 - Device ID Type:
Primary
Item #2 - 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:
K964072
Supplement Number:
000