AccessGUDID - DEVICE: AMSure® Disposable Vaginal Speculum (10704411002260)

GUDID

Device Identifier (DI) Information

Brand Name: AMSure® Disposable Vaginal Speculum
Version or Model: 1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AS032M
Company Name: AMSINO INTERNATIONAL, INC.

Primary DI Number: 10704411002260
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 825673239 *Terms of Use

Device Description: AMSure® Disposable Vaginal Speculum Graves Style, Clean, Ready For Use

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:	Yes
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?
37468	Vaginal speculum, single-use	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 typically 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 to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HIB	Speculum, Vaginal, Nonmetal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: dc97dc92-54c4-4f53-8b3e-2c28faae36e7
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016