AccessGUDID - DEVICE: Video Camera Insert (00878953005553)

GUDID

Device Identifier (DI) Information

Brand Name: Video Camera Insert
Version or Model: 0010-0721
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0010-0721
Company Name: BOSTON SCIENTIFIC CORPORATION

Primary DI Number: 00878953005553
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 021717889 *Terms of Use

Device Description: Video Camera Insert - For Rigid Endoscopes

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?
36308	Operator eye protection laser filter	An eyepiece intended to be fitted to a device used during a laser procedure (e.g., surgical laser system, endoscope, surgical microscope) to protect the operator's eyes from laser energy. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FEM	Accessories, Photographic, For Endoscope (Exclude Light Sources)

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: 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: 1.25 Inch Diameter

Device Record Status

Public Device Record Key: eec14e52-8ac4-40aa-8ced-f8ca0c81ccbf
Public Version Date: June 02, 2023
Public Version Number: 8
DI Record Publish Date: September 24, 2016