AccessGUDID - DEVICE: PROVE (STRAIGHT) (04953170183133)

GUDID

Device Identifier (DI) Information

Brand Name: PROVE (STRAIGHT)
Version or Model: MH-112
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: OLYMPUS MEDICAL SYSTEMS CORP.

Primary DI Number: 04953170183133
Issuing Agency: GS1
Commercial Distribution End Date: March 06, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 711789789 *Terms of Use

Device Description: No description.

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?
64417	Soft-tissue ultrasonic surgical system holder/tip, reusable	A hand-held component of an ultrasonic surgical system which includes a holder with controls and a surgical endpiece (tip) intended to be connected to a system transducer (not included) whereby the tip oscillates (vibrates) at high frequency in order to fragment soft-tissue cells for cutting and/or coagulating soft tissue during surgery. It may be referred to as a handpiece but does not include a transducer; the tip is available in a variety of forms and sizes, is typically made of metal, and may include a disposable tube to cover the shaft of the tip. This device is utilized in a variety of surgical disciplines. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LFL	Instrument, ultrasonic surgical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032066	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization
Ethylene Oxide

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: c9509414-c5d9-471d-9a84-2f52e3fe7ac3
Public Version Date: April 22, 2024
Public Version Number: 6
DI Record Publish Date: September 21, 2016