AccessGUDID - DEVICE: THE BULLET, Alcon (00380651092037)

GUDID

Device Identifier (DI) Information

Brand Name: THE BULLET, Alcon
Version or Model: 8065109203
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Alcon Laboratories, Inc.

Primary DI Number: 00380651092037
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 008018525 *Terms of Use

Device Description: The BULLET Shielded Endo Illuminator, Wide Angle Tip, 20Ga, 2.1m

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":	Yes
For Single-Use:	Yes
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?
32241	Fibreoptic operating light system	A system of lights intended to be used in the operating room (OR) to illuminate the surgical site over a prolonged period for optimal visualization of small, low-contrast objects at varying depths or through small incisions. It operates through light provided by a light source, usually located outside of the surgical field, which is delivered through fibreoptic cables to the site of operation. The cables will be mounted, e.g., from the ceiling or attached to a suitable floor mount, or they may possibly connect directly to the surgeons head-worn head light.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MPA	Endoilluminator

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 20 Gauge
Length: 2.1 Meter

Device Record Status

Public Device Record Key: 6ad4c625-98f0-4819-be1b-0579533e4304
Public Version Date: March 21, 2024
Public Version Number: 3
DI Record Publish Date: September 24, 2016