AccessGUDID - DEVICE: NA (07613327060195)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0502777500
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0502777500
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327060195
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Grasper, Semi-flexible, Double-action, 7 Fr.

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
Flexible endoscopic grasping forceps, reusable	A flexible, hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs or claws which are operated by a control handle attached at the proximal end of the instrument; it is not an electrosurgical instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Flexible endoscopic grasping forceps, reusable

A flexible, hand-held, manual device used in combination with a compatible endoscope to grasp tissue (typically atraumatically) or foreign bodies. It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a pair of scissors-like grasping tongs or claws which are operated by a control handle attached at the proximal end of the instrument; it is not an electrosurgical instrument. It is introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
KQT	EVACUATOR, GASTRO-UROLOGY
HIH	HYSTEROSCOPE (AND ACCESSORIES)
FAS	ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL
FAJ	Cystoscope and accessories, flexible/rigid

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
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 41.0 Centimeter

Device Record Status

Public Device Record Key: d4dcdd83-aa39-4f8e-b0b5-14ad22cb7c62
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016