AccessGUDID - DEVICE: NA (07613327052404)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 0250080204
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0250-080-204
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327052404
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: Reducer Sleeve, 12.5/11.0 mm to 5.5 mm

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?
37090	Endoscope assembly adaptor	A connecting component of a flexible or rigid endoscope assembly intended to be used to join one or more endoscope elements to create a complete endoscope assembly, or to enable the connection of other devices (e.g., a laser). It may also be fitted with stop-cocks or instrument ports for the introduction of devices (e.g., catheters), fluids, gases, or to perform aspiration. This is a reusable device.	Obsolete	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
No Device Sizes

Device Record Status

Public Device Record Key: 1a70d07f-6922-4a34-8f5e-611f34081a11
Public Version Date: December 07, 2018
Public Version Number: 5
DI Record Publish Date: September 23, 2016