AccessGUDID - DEVICE: AIM CLEAR FLUSH (B508EA1035)

GUDID

Device Identifier (DI) Information

Brand Name: AIM CLEAR FLUSH
Version or Model: A1-1035
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ADVANCED INSTRUMENTATION FOR MEDICINE,INC.

Primary DI Number: B508EA1035
Issuing Agency: HIBCC
Commercial Distribution End Date: June 20, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 080478537 *Terms of Use

Device Description: AIM CLEAR FLUSH DOLPHIN DISSECTOR 5MM 35 CM ROTO MONOPOLAR

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?
36083	Laparoscopic dissection spatula	A rigid laparoscopic device designed for the blunt dissection of broadly implanted adhesions during a therapeutic laparoscopy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GCJ	Laparoscope, General & Plastic Surgery

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: ac0e8ec2-45a7-4faa-80e8-4ef499c7fed5
Public Version Date: March 08, 2019
Public Version Number: 3
DI Record Publish Date: June 12, 2017