AccessGUDID - DEVICE: AIM CLEAR FLUSH (B508EA11020)

GUDID

Device Identifier (DI) Information

Brand Name: AIM CLEAR FLUSH
Version or Model: A1-1020
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: ADVANCED INSTRUMENTATION FOR MEDICINE,INC.

Primary DI Number: B508EA11020
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 MARYLAND DISSECTOR, ROTO CLEAR, MONOPOLAR, 5MM, 35CM

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?
33596	Endoscopic electrosurgical handpiece/electrode, monopolar, reusable	An electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps or snare with ring handles, rigid probe with controls) and requires a patient contact return electrode to complete the circuit. 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: 79346804-3a03-47d4-800b-7d6887c72b5a
Public Version Date: March 11, 2019
Public Version Number: 3
DI Record Publish Date: May 02, 2017