AccessGUDID - DEVICE: MicroFrance® (10381780106876)

GUDID

Device Identifier (DI) Information

Brand Name: MicroFrance®
Version or Model: MCLS122-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MCLS122-1
Company Name: INTEGRA MICROFRANCE

Primary DI Number: 10381780106876
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 276593071 *Terms of Use

Device Description: MicroFrance® Sataloff left light fiber for laryngoscope MCL122

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?
34174	ENT transilluminator	A hand-held instrument intended to be used to illuminate sinus tissue during an ear/nose/throat (ENT) procedure to render the tissue translucent for examination. It is connected through a light cable, that may or may not be part of the device, to a light source that generates the light. Its exterior is typically made of high-grade stainless steel; it has a fibreoptic bundle core that conducts the light to the target site. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EQH	SOURCE, CARRIER, FIBEROPTIC LIGHT

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: 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: 14ee14ac-e1e6-405f-820c-0d965812c740
Public Version Date: May 15, 2023
Public Version Number: 3
DI Record Publish Date: January 10, 2018

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)654-2873
Email: custsvcnj@integralife.com

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