AccessGUDID - DEVICE: ABN Deluxe Penlight (08997021263526)

GUDID

Device Identifier (DI) Information

Brand Name: ABN Deluxe Penlight
Version or Model: PL-900-212
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SUGIH INSTRUMENDO ABADI, PT

Primary DI Number: 08997021263526
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 726548899 *Terms of Use

Device Description: ABN Deluxe Penlight is a medical device used as an assessment tool especially small body parts such as eyes, ears, nose, and mouth.

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?
38832	Hand-held examination/treatment light	A small hand-held battery-powered light intended to beused as a personal light source to provide light for local examination, inspection, and treatment of the patient. It may be torch-like in design and can have a magnifying lens to augment the lighting effect. It will typically be found in an examination room, doctor's office, on a medical trolley, in an emergency kit, or carried in a pocket. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KYT	Light, Examination, Medical, Battery Powered

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
No Device Sizes

Device Record Status

Public Device Record Key: 61db539a-6d9d-42b9-895f-5bae19f38f93
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 09, 2023