AccessGUDID - DEVICE: Ambler Value Line (00190660178024)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Value Line
Version or Model: Fansler proctoscope
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 86-288
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660178024
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Fansler proctoscope, 2 3/8'' long x 1 1/4'' diameter, open at top

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?
35351	Rectal speculum	A hand-held manual surgical instrument intended to be used to expand or stretch the rectal orifice/canal after it is inserted and opened. It is comprised of two arms joined at a pivot point and is available in various sizes, shapes, and contours; it is usually made of stainless steel. The instrument is used for examination or for the insertion of other instrumentation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FXE	SPECULUM, NON-ILLUMINATED

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: 539b31eb-a782-4cec-9252-f07ba7806adc
Public Version Date: January 12, 2021
Public Version Number: 1
DI Record Publish Date: January 04, 2021