AccessGUDID - DEVICE: 1188 (07613327054682)

GUDID

Device Identifier (DI) Information

Brand Name: 1188
Version or Model: 1188000020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 1188-000-020
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327054682
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: HD Camera Extension Cable

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?
47847	Orthopaedic implant-instrument extension adaptor, reusable	A connecting device designed to join an orthopaedic implant to a surgical instrument, or a surgical instrument to another instrument, typically to create an extension for removal of the implant (e.g., during a percutaneous interspinous distraction procedure for the removal of a distraction sleeve), or to connect two devices with incompatible interfaces. It is typically made from high-grade stainless steel and/or synthetic material and is available in a variety of sizes and lengths. This is a reusable device.	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: Yes

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 20.0 Feet

Device Record Status

Public Device Record Key: 108c5ee3-b44a-4118-a093-b8eaad76ab67
Public Version Date: May 03, 2023
Public Version Number: 4
DI Record Publish Date: September 23, 2016