Device
Rosen Circular Cut Knife Straight Fig. 3 15 cm - 6" Dia 2.6 mm Stainless Steel
Manufacturer
SURTEX INSTRUMENTS LTD.
SURTEX INSTRUMENTS LTD.
Model: OT-420-03
DI: 05056111346372
Status: New
MRI: MR Conditional
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Description
Rosen Circular Cut Knife Straight Fig. 3 15 cm - 6" Dia 2.6 mm Stainless Steel
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
5d076cac-994e-429a-84fb-309b3b3168f8
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:
05056111346372
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 35141
Name: Scalpel, reusable
Definition:
A hand-held manual surgical instrument constructed as a one-piece handle and scalpel blade (not an exchangeable component) used by the operator to manually cut or dissect tissue. The device is typically made of high-grade stainless steel alloy. This is a reusable device.
FDA Product Codes
EMF
KNIFE, SURGICAL