AccessGUDID - DEVICE: RELIEVA LUMA (10705031063358)

GUDID

Device Identifier (DI) Information

Brand Name: RELIEVA LUMA
Version or Model: SISLGCAWOLF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SISLGCAWOLF
Company Name: ACCLARENT, INC.

Primary DI Number: 10705031063358
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 361092450 *Terms of Use

Device Description: RELIEVA LUMA LIGHT GUIDE CABLE ADAPTER - WOLF / DYONICS

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?
48144	Paranasal sinus-illumination light guide cable	A sterile device designed to transmit cold light via a guidewire into the sinus cavities to provide illumination of the operative site during diagnostic and therapeutic procedures in conjunction with other nasal and sinus devices. It is typically a flexible light cable with a fibreoptic core which tapers at the distal end into a long, thin, probe that is capable of being manoeuvred into the various cavities; the proximal end will attach to an appropriate light source. This is a single-use 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 [?]
Hydrogen Peroxide
Moist Heat or Steam Sterilization
High-level Disinfectant

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a dry, clean and safe place at room temperature

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 86aa68ac-f01f-4763-8a88-14d4d69f1504
Public Version Date: November 21, 2024
Public Version Number: 6
DI Record Publish Date: September 01, 2017

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

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

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