AccessGUDID - DEVICE: NA (04250321527847)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 610K0114-50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Söring GmbH

Primary DI Number: 04250321527847
Issuing Agency: GS1
Commercial Distribution End Date: January 01, 2020
Device Count: 50
Labeler D-U-N-S® Number*: 322238346 *Terms of Use

Device Description: Flue, for 94-106/94-106-HF

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?
45184	Ultrasonic surgical system flue	A sterile device used to encompass the distal end of a dedicated ultrasonic surgical system handpiece and tip to provide a pathway for the delivery of irrigation fluid. The device helps to concentrate the fluid at the tip of the handpiece, remove some of the heat generated during surgery, eliminate misting that can impair visibility of the surgical site, and reduce the amount of irrigant needed. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
BTA	Pump, Portable, Aspiration (Manual Or Powered)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K992026	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 777ff6ef-41ae-4454-8d36-46ad0a475262
Public Version Date: November 09, 2021
Public Version Number: 4
DI Record Publish Date: September 17, 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
No Package DIs found

Secondary DI

[?]

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

Unit of Use DI

[?]

Unit of Use DI Number: 04250321527823 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: 844 476 7464
Email: UDI-inquiry@soering.com

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