AccessGUDID - DEVICE: Minerva Hegar Dilator (3 Pack) (00862393000179)

GUDID

Device Identifier (DI) Information

Brand Name: Minerva Hegar Dilator (3 Pack)
Version or Model: MIN8MM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MIN8MM
Company Name: Minerva Surgical, Inc.

Primary DI Number: 00862393000179
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 829616478 *Terms of Use

Device Description: Minerva Hegar Dilator (3 Pack)

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":	Yes
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?
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
HDQ	Dilator, Cervical, Fixed Size

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: 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: b4448d7d-29fa-4d94-8d17-3565968f018f
Public Version Date: April 04, 2023
Public Version Number: 7
DI Record Publish Date: June 27, 2017