AccessGUDID - DEVICE: HNM Medical (00842962128695)

GUDID

Device Identifier (DI) Information

Brand Name: HNM Medical
Version or Model: HNM-1-52-8614
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HNM-1-52-8614
Company Name: HNM STAINLESS, LLC.

Primary DI Number: 00842962128695
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806754185 *Terms of Use

Device Description: BUMM UTERINE CURETTE, 11", MALLEABLE SHAFT, SHARP, 17MM TIP

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):	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?
46870	Intrauterine scoop	A heavy, hand-held, manual surgical instrument with a spoon-like, sharp-edged distal end on a long shaft that is used to access and scrape (gouge or scoop out) a particular area of the lining of the uterus for its removal during a gynaecological procedure. The device is rigid and typically made of high-grade stainless steel. The scoop at the distal end is available in various shapes and sizes; there is a handle at the proximal 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: c4c7aa23-dd54-424d-a9e1-dd1b52abf493
Public Version Date: February 14, 2023
Public Version Number: 1
DI Record Publish Date: February 06, 2023