Device
Doyen Myoma Screw 14.5 cm - 5 3/4" Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: GY-653-14
DI: 05055445965457
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Doyen Myoma Screw 14.5 cm - 5 3/4" Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
d4e8595e-8a53-4bc7-a550-949e42c14b5d
Distribution Status:
In Commercial Distribution
DUNS Number:
216232502
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
05055445965457
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35874
Name: Myoma screw, reusable
Definition:
A hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. This is a reusable device.
FDA Product Codes
GDG
HOOK, SURGICAL, GENERAL & PLASTIC SURGERY