AccessGUDID - DEVICE: Fluid Safe (07613327055290)

GUDID

Device Identifier (DI) Information

Brand Name: Fluid Safe
Version or Model: 0502100000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0502-100-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327055290
Issuing Agency: GS1
Commercial Distribution End Date: December 02, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 187502109 *Terms of Use

Device Description: 3000 CC, 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:	Yes
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?
36122	Hysteroscopic irrigation/insufflation system	A mains electricity (AC-powered) device assembly used during endoscopic procedures of the uterus (i.e., hysteroscopy) to distend (expand by pressure) the uterus by filling the uterine cavity with a liquid to improve visualization (e.g., a hysteroscope) and enlarge the surgical field; it also circulates the fluid to provide irrigation that will remove tissue/debris from the site. This system will typically electronically monitor the volume differential between the irrigation fluid flowing into and out of the uterus. Some distention systems are combined with gynaecologic resectoscopes.	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: 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: 291cfb0a-3365-4529-96da-b952beb8624c
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016