Clarke-Reich Macro

GUDID 00888937011432

Laparoscopic Knot Pusher; 5-0 and Larger; 45cm working length

Coopersurgical, Inc.

Needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable Suturing needle holder, reusable

Primary Device ID	00888937011432
NIH Device Record Key	fafa98ed-5f3e-440b-a23c-4e50009986d7
Commercial Distribution Status	In Commercial Distribution
Brand Name	Clarke-Reich Macro
Version Model Number	M4601P
Company DUNS	801895244
Company Name	Coopersurgical, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter
Outer Diameter	5 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00888937011432 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K903560

FDA Product Code

HET	Laparoscope, Gynecologic (And Accessories)