AccessGUDID - DEVICE: Ambler Surgical (00190660127619)

GUDID

Device Identifier (DI) Information

Brand Name: Ambler Surgical
Version or Model: Ostium probe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 44-947
Company Name: AMBLER SURGICAL CORP.

Primary DI Number: 00190660127619
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 015272206 *Terms of Use

Device Description: Ostium probe, 7 1/2'', double-ended, curved, one end at 90 degrees, hexagonal handle

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?
35252	Fistula probe	A slender, rod-like, hand-held manual surgical instrument made of flexible metal, with a blunt bulbous tip, designed for use in abnormal body passages or communications (fistulas), usually between two internal organs, or leading from an internal organ to an external cavity or to the surface of the body. It is mostly used to explore and/or dilate strictures inside a fistula. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KAK	PROBE, ENT

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: f10917ab-a68f-4883-b3f6-8b6366bb317d
Public Version Date: January 15, 2021
Public Version Number: 1
DI Record Publish Date: January 07, 2021