AccessGUDID - DEVICE: NA (07613327058208)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0250080324
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0250-080-324
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327058208
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Insert, Oviduct Forceps

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":	No
For Single-Use:	No
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 Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Laparoscopic grasping forceps, reusable	A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles that may include a ratchet mechanism; a long slender shaft; and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., duckbill, alligator) controlled by a knob at the handle. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Laparoscopic grasping forceps, reusable

A rigid surgical instrument designed to be introduced through a laparoscope primarily for grasping and manipulating tissues during a laparoscopic surgical procedure. It is a hand-held device typically with scissors-like handles that may include a ratchet mechanism; a long slender shaft; and one of a variety of distal tips with single or double action and frequently rotating jaws (e.g., duckbill, alligator) controlled by a knob at the handle. This is a reusable device.

FDA Product Code

[?]

Product Code	Product Code Name
OCZ	Endoscopic grasping/cutting instrument, non-powered

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 5.0 Millimeter
Length: 33.0 Centimeter

Device Record Status

Public Device Record Key: 4c58b729-4199-4de8-ba25-3641fb50b529
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016