AccessGUDID - DEVICE: N/A (00885825017934)

GUDID

Device Identifier (DI) Information

Brand Name: N/A
Version or Model: N/A
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 3632
Company Name: STRYKER SUSTAINABILITY SOLUTIONS, INC.

Primary DI Number: 00885825017934
Issuing Agency: GS1
Commercial Distribution End Date: October 27, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 020198912 *Terms of Use

Device Description: Raptor/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":	No
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?
61822	General-purpose surgical scissors, reprocessed	A non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is available in various designs and sizes. This is a previously used single-use device that has been processed for an additional single-use patient application.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NUJ	ELECTROSURGICAL, CUTTING & COAGULATION ACCESSORIES, LAPAROSCOPIC & ENDOSCOPIC, REPROCESSED

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
No Device Sizes

Device Record Status

Public Device Record Key: af7708e6-ecd9-4f22-ad5b-4dd5711e94ab
Public Version Date: February 21, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2016