AccessGUDID - DEVICE: Genesys HTA Scope Adapter, WOLF (00850033976175)

GUDID

Device Identifier (DI) Information

Brand Name: Genesys HTA Scope Adapter, WOLF
Version or Model: M006550340
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M006550340
Company Name: Minerva Surgical, Inc.

Primary DI Number: 00850033976175
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829616478 *Terms of Use
Previous DI: 08714729469773

Device Description: WOLF Scope Adapter, for use only with Genesys HTA System

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?
37086	Endoscope sheath, reusable	A component of a rigid or flexible endoscope assembly designed as a tube through which an endoscope (e.g., hysteroscope) and endoscopic elements are introduced and assembled to create a complete operative endoscopic unit; it is also designed to function as a protective barrier to isolate the endoscope from patient contact and prevent contamination of the endoscope controls during a procedure. It typically contains ports to enable the insertion of instruments (through the endoscope or through independent working channels), insufflation ports, valves and connectors. It is made of plastic and metal materials. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NWW	Hysteroscope Accessories

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: 5a6c485f-ea3e-4565-8302-c58903f1d6b6
Public Version Date: October 27, 2022
Public Version Number: 1
DI Record Publish Date: October 19, 2022