AccessGUDID - DEVICE: NA (07613252027232)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 5450850001
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 5450850001
Company Name: STRYKER CORPORATION

Primary DI Number: 07613252027232
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: Reusable Suction Canister

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?
44778	Soft-tissue ultrasonic surgical system	An assembly of devices that converts high frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It typically includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and possibly an integrated irrigation/suction system.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KDQ	BOTTLE, COLLECTION, VACUUM

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 99a174b6-2796-4a4a-a343-b12869e3455b
Public Version Date: January 01, 2024
Public Version Number: 3
DI Record Publish Date: November 15, 2017