AccessGUDID - DEVICE: Hayden Medical (00840319731857)

GUDID

Device Identifier (DI) Information

Brand Name: Hayden Medical
Version or Model: L315-104C
Commercial Distribution Status: In Commercial Distribution
Catalog Number: L315-104C
Company Name: Hayden Medical, Inc.

Primary DI Number: 00840319731857
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 618214410 *Terms of Use

Device Description: Weisman-Graves LLETZ Speculum w/ disposable straw connection, right open, medium 4" x 1-1/2", NON-CONDUCTIVE

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):	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?
35352	Vaginal speculum, reusable	A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened at an angle. It is typically made of stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDF	SPECULUM, VAGINAL, METAL

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: 15192776-f48d-43b2-a7e9-cd33bc1bd6fa
Public Version Date: August 24, 2022
Public Version Number: 1
DI Record Publish Date: August 16, 2022