AccessGUDID - DEVICE: 1188 (07613327063318)

GUDID

Device Identifier (DI) Information

Brand Name: 1188
Version or Model: 1188010000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1188010000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327063318
Issuing Agency: GS1
Commercial Distribution End Date: November 23, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: Video Camera Console

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?
36739	Camera control unit	A mains electricity (AC-powered) unit intended to be used to remotely steer a camera's movements and adjustments (e.g., a miniaturized camera) in a clinical setting. It is typically situated outside the field of operation and can be adjusted upon instructions from the surgeon/operator, or it may be automated to a certain degree. Some remote control units may have extensive functions and may supply the camera with electric current and adjustments such as light intensity, colour control, automatic exposure, and automatic flash. Those types used in ophthalmology may operate the raise/lower function of the ophthalmic instrument table upon which the camera is situated.	Active	false

FDA Product Code

[?]

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

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K142603	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 963029b7-f991-4409-ad5e-3b8520dc66a7
Public Version Date: November 23, 2022
Public Version Number: 5
DI Record Publish Date: September 23, 2016