AccessGUDID - DEVICE: Pharos HD System (00851610007374)

GUDID

Device Identifier (DI) Information

Brand Name: Pharos HD System
Version or Model: P003500
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: LONG ISLAND TECH

Primary DI Number: 00851610007374
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 030256600 *Terms of Use

Device Description: Light, Surgical, Accessory

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:	Yes
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?
32265	Surgical video camera	An electro-optical device (e.g., a CCD) designed to obtain moving-picture documentation of an open surgical procedure. The device is designed for transducing visual images as a sequence of electronic data following a pre-established standard; the images are usually displayed sequentially on the screen of a monitor as a video image. The device may include audio recording capabilities.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KQM	Camera, Surgical And Accessories

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
Handling Environment Temperature: between 60 and 80 Degrees Fahrenheit
Handling Environment Atmospheric Pressure: between 86 and 106 KiloPascal
Handling Environment Humidity: between 45 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between 32 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d70962ea-ea47-40cf-94a6-41e927c4e4bf
Public Version Date: November 10, 2020
Public Version Number: 1
DI Record Publish Date: November 02, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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