Device
UNIFY Micro Silk Sutures, Size 6-0, 6.5mm 3/8 Circle Spatula Double Needle, 18in. Black.
Manufacturer
APPLIED DENTAL, INC.
APPLIED DENTAL, INC.
Model: XXS-S618S6D
Catalog: XXS-S618S6D
DI: 00814639026832
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
UNIFY Micro Silk Sutures, Size 6-0, 6.5mm 3/8 Circle Spatula Double Needle, 18in. Black.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
aa1c6123-03e2-4be2-998b-7cff2e4df5f3
Distribution Status:
In Commercial Distribution
DUNS Number:
017524666
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:
Yes
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:
10814639026839
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
12
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00814639026832
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00814639026832
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
carton
Item #3 - Device ID:
20814639026836
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
100
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
10814639026839
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 13910
Name: Silk suture
Definition:
A natural, non-bioabsorbable thread made from raw silk spun by silkworms (typically coated with beeswax or silicone) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It provides temporary wound support until the wound sufficiently heals to withstand normal stress. Although classified as a "non-bioabsorbable" material, it may be digested by proteolysis after an extended period of time. This is a single-use device.
FDA Product Codes
GAP
Suture, Nonabsorbable, Silk
Premarket Submissions
Submission Number:
K161633
Supplement Number:
000