Device
Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each...
Manufacturer
MERIL ENDO SURGERY PRIVATE LIMITED
MERIL ENDO SURGERY PRIVATE LIMITED
Model: MLCR100-3.8
DI: 08906070909637
Status: New
MRI: MR Unsafe
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Description
Mirus™ Linear Cutter stapler and the Reload have two groups of staple lines in the target area, both of which are composed of a double row of titanium staples interlaced with each other and automatically cut the tissues between the two groups of staple lines when suturing. There are three suturing lengths of 60mm, 80mm and 100mm. The cartridge/ reload for Mirus™ Linear Cutter are supplied separately.
Sterilization
Device Sterile:
Yes
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
75456922-81a6-4407-8b49-3878cf1158b5
Distribution Status:
In Commercial Distribution
DUNS Number:
870914838
Device Count:
6
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 - Device ID:
18906070909634
Item #1 - Device ID Type:
Unit of Use
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
08906070909637
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 59870
Name: Open-surgery manual linear cutting stapler, single-use
Definition:
A sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the expeditious transection/resection of tissues and creation of anastomoses. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it cuts the tissues (e.g., colon) and simultaneously applies single or multiple linear rows of surgical staples to the resulting ends, eliminating the need for temporary clamping. The staples and cutting blade may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.
FDA Product Codes
GDW
Staple, Implantable
Premarket Submissions
Submission Number:
K200320
Supplement Number:
000