AccessGUDID - DEVICE: HNM MEDICAL (00842962124659)

GUDID

Device Identifier (DI) Information

Brand Name: HNM MEDICAL
Version or Model: HNM-1-51-1502
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HNM-1-51-1502
Company Name: HNM STAINLESS, LLC.

Primary DI Number: 00842962124659
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 806754185 *Terms of Use

Device Description: GALL STONE SCOOP, 9 1/2", MEDIUM, DOUBLE ENDED

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: c67cb87b-2507-4d16-a583-9b5d2e0287dd
Public Version Date: April 20, 2023
Public Version Number: 1
DI Record Publish Date: April 12, 2023

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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