AccessGUDID - DEVICE: GYRUS ACMI, INC (00821925041387)

GUDID

Device Identifier (DI) Information

Brand Name: GYRUS ACMI, INC
Version or Model: 70230946
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Gyrus ACMI, LLC

Primary DI Number: 00821925041387
Issuing Agency: GS1
Commercial Distribution End Date: October 27, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 007198742 *Terms of Use

Device Description: PENTAX LIGHT SOURCE CONNECTOR FOR USE WITH GYRUS ENT FLEXIBLE AND RIG

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?
46113	Endoscopic light source adaptor	A device that provides an optical interface to match the light characteristics from an external light source (from a different endoscope manufacturer or model) to the fibreoptic bundles of an endoscope. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EOB	NASOPHARYNGOSCOPE (FLEXIBLE OR RIGID)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K932988	000

Device Exempt from Premarket Submission: No 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: abe3013a-c1b6-4792-bb4b-e1def281e6c6
Public Version Date: September 02, 2024
Public Version Number: 7
DI Record Publish Date: October 03, 2016