AccessGUDID - DEVICE: 1288 (07613327063431)

GUDID

Device Identifier (DI) Information

Brand Name: 1288
Version or Model: 1288310130
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1288310130
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327063431
Issuing Agency: GS1
Commercial Distribution End Date: July 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: HD Urology Camera Head with 16.5 mm Integrated Coupler

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?
35958	Endoscope video camera	An electro-optical device (e.g., a CCD) designed to be attached, either directly or with an adaptor, to a flexible or rigid endoscope to allow real-time viewing of the internal anatomy during an endoscopic surgical procedure and to obtain moving-picture documentation of endoscopic findings and procedures. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, general & plastic surgery

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132785	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Ethylene Oxide
Peracetic Acid
Hydrogen Peroxide
Liquid Chemical

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: 7c9179da-88e2-4796-916b-c6f0b889409f
Public Version Date: July 31, 2023
Public Version Number: 5
DI Record Publish Date: September 23, 2016