AccessGUDID - DEVICE: Minerva Single Sterile Disposable Handpiece (00862393000162)

GUDID

Device Identifier (DI) Information

Brand Name: Minerva Single Sterile Disposable Handpiece
Version or Model: MIN9770
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIN9770
Company Name: Minerva Surgical, Inc.

Primary DI Number: 00862393000162
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 829616478 *Terms of Use

Device Description: STERILE MINERVA Disposable Handpiece Contents: (1) One Single use STERILE Minerva ES Disposable Handpiece (1) One Single Use STERILE Syringe (1) One Single Use STERILE 8mm Hegar Dilator (1) One Single use NON-STERILE Desiccant (1) One NON-STERILE Handpiece Instructions For Use (1) One NON-STERILE Dilator Instructions For Use

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
62227	Inert gas-enhanced endoscopic electrosurgical submucosal lift/resection instrument	A flexible, invasive, endoscopic device intended to deliver both: 1) a submucosal lifting solution; and 2) electrosurgical current within a stream of inert gas [e.g., argon (Ar), helium (He)] (in a monopolar configuration) to tissues for cutting/coagulation. It is typically intended to treat gastrointestinal mucosal lesions through lifting of diseased mucosa over a bubble of fluid, and subsequent ablation of the diseased area by gas plasma coagulation. It is a long, thin electrode/luminal needle intended to be connected to a parent device (i.e., inert gas-enhanced electrosurgical system generator/gas delivery unit, and fluid pump); it does not include controls. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MNB	Device, Thermal Ablation, Endometrial

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: 624596b2-b2d6-44c1-a98d-e6897c7fd730
Public Version Date: April 04, 2023
Public Version Number: 11
DI Record Publish Date: June 27, 2017