AccessGUDID - DEVICE: NA (07613327052336)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0250080157
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0250-080-157
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327052336
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Obturator for Hasson Cannula

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 Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35692	Rigid endoscope obturator	An endoscopic device that is a component of a rigid endoscope assembly that has a distally rounded, solid, head or end that is placed into the sheath of a rigid endoscope in order to fill out the sheath's lumen (open end), thereby assisting its insertion into the body and protecting against damage to the patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEI	ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935237	000

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
Device Size Text, specify: Diameter: 5.5 Millimeter

Device Record Status

Public Device Record Key: 81583e34-6390-4bb6-a8a2-863cf3e57eb5
Public Version Date: December 07, 2018
Public Version Number: 5
DI Record Publish Date: September 23, 2016