AccessGUDID - DEVICE: HNM MEDICAL (00842962106488)

GUDID

Device Identifier (DI) Information

Brand Name: HNM MEDICAL
Version or Model: HBI-RD003
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: HBI-RD003
Company Name: HNM STAINLESS, LLC.

Primary DI Number: 00842962106488
Issuing Agency: GS1
Commercial Distribution End Date: December 07, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 806754185 *Terms of Use

Device Description: CURETTE ENDOMETRIAL SAMPLER W/TWIST AND LOCK SYRINGE, 3MM, BOX OF 25

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
MDM	Instrument, Manual, 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: 9860e6b8-f108-4a4b-88a1-a57d8958bde9
Public Version Date: December 08, 2023
Public Version Number: 2
DI Record Publish Date: April 01, 2023