AccessGUDID - DEVICE: HNM MEDICAL (00842962162576)

GUDID

Device Identifier (DI) Information

Brand Name: HNM MEDICAL
Version or Model: H-M0014/SGL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: H-M0014/SGL
Company Name: HNM STAINLESS, LLC.

Primary DI Number: 00842962162576
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 806754185 *Terms of Use

Device Description: PREFERRED FIRM DISPOSABLE ENDOMETRIAL CURETTE, 3mm

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:	No
Prescription Use (Rx):	No
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?
46871	Endometrial biopsy curette	A hand-held, surgical instrument used to for the removal of small amounts of endometrial secretions and/or tissue from the uterus for biopsy purposes. It is typically made of high-grade stainless steel and is available in a variety of designs: 1) a long, thin, instrument with very small spoon-like scoop terminating at either end and a centrally placed handle; 2) a long, thin tubular device with a serrated opening at the distal end and a connection to a suction device or a syringe at the proximal end; or 3) a single-ended device with a scraper at the distal end. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZS	Curette, Surgical, General Use

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: e3ac7c6e-0ff0-45b9-83a4-4076f5dd9011
Public Version Date: January 25, 2024
Public Version Number: 3
DI Record Publish Date: May 27, 2023