AccessGUDID - DEVICE: Epix Laparoscopic Grasper (00607915110147)

GUDID

Device Identifier (DI) Information

Brand Name: Epix Laparoscopic Grasper
Version or Model: C4130
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: APPLIED MEDICAL RESOURCES CORPORATION

Primary DI Number: 00607915110147
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187129135 *Terms of Use

Device Description: Disposable Grasper

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61839	Rigid endoscopic tissue manipulation forceps, single-use	A rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWV	Laparoscopic Accessories, Gynecologic

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5 Millimeter
Length: 35 Centimeter

Device Record Status

Public Device Record Key: efdf2796-c576-4911-a186-c2f7b35c87ef
Public Version Date: July 10, 2024
Public Version Number: 3
DI Record Publish Date: August 30, 2016