AccessGUDID - DEVICE: RELIEVA FLEX (10705031063426)

GUDID

Device Identifier (DI) Information

Brand Name: RELIEVA FLEX
Version or Model: GC070CRF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: GC070CRF
Company Name: ACCLARENT, INC.

Primary DI Number: 10705031063426
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 361092450 *Terms of Use

Device Description: RELIEVA FLEX SINUS GUIDE CATHETER F-70C

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):	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?
48142	Paranasal sinus guide-catheter	A sterile cannula-like catheter consisting of a tube with a tip designed to facilitate placement of other devices into or near different sinus ostia. It is used to provide a channel to access the sinus space during diagnostic and therapeutic procedures. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KAM	CANNULA, SINUS

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Store in a cool, dry place

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1b1894c2-736a-45bb-ba1b-5aea044fc896
Public Version Date: January 22, 2020
Public Version Number: 4
DI Record Publish Date: October 01, 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
20705031063423	5	10705031063426		In Commercial Distribution	BOX

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

Customer Contact

[?]

Phone: +1(877)775-2789
Email: xx@xx.xx

Phone: +1(650)687-5888
Email: xx@xx.xx

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