AccessGUDID - DEVICE: ESI (B3968701340)

GUDID

Device Identifier (DI) Information

Brand Name: ESI
Version or Model: 87-0134
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: FTT MEDICAL, INC.

Primary DI Number: B3968701340
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 002212793 *Terms of Use

Device Description: REPLACEMENT FIBER OPTIC LIGHT CARRIER, ACMI FITTING. FOR ENDOCAVITY IRRADIATION PROCTOSCOPES.

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?
35255	Optical proctoscope, reusable	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the rectum and anus. It is inserted into the body through the anus during proctoscopy. The anatomical images are illuminated by a built-in or external light source and can be viewed by the user through direct or magnified viewing, or a fibreoptic bundle. This device is longer than an anoscope to provide a deeper view. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCF	Proctoscope

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: 463c6a3a-af4d-4502-a05b-95fff8b3ba6a
Public Version Date: November 17, 2023
Public Version Number: 4
DI Record Publish Date: September 16, 2016