AccessGUDID - DEVICE: Adlite™ (00634782013288)

GUDID

Device Identifier (DI) Information

Brand Name: Adlite™
Version or Model: 351PZ
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 351PZ
Company Name: AMERICAN DIAGNOSTIC CORP

Primary DI Number: 00634782013288
Issuing Agency: GS1
Commercial Distribution End Date: April 19, 2019
Device Count: 10
Labeler D-U-N-S® Number*: 108999095 *Terms of Use

Device Description: Disposable Penlight, 6/pkg,White w/Pupil Gauge, Generic

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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: c46e0a3d-ca7d-4a9d-b552-702cd6643469
Public Version Date: April 22, 2019
Public Version Number: 3
DI Record Publish Date: November 04, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
00634782513221	10	00634782813222	2019-04-19	Not in Commercial Distribution	Master Case
00634782813222	6	00634782013288	2019-04-19	Not in Commercial Distribution	Inner Pack