AccessGUDID - DEVICE: debritom+ (B724100000050)

GUDID

Device Identifier (DI) Information

Brand Name: debritom+
Version or Model: 1000.0005
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Medaxis AG

Primary DI Number: B724100000050
Issuing Agency: HIBCC
Commercial Distribution End Date: March 31, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 480870674 *Terms of Use

Device Description: debritom+ micro water jet device

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?
47893	Surgical/orthopaedic lavage system power supply	A dedicated mains electricity (AC-powered) device designed to convert mains current into the voltage required by a line-powered surgical lavage kit handpiece, to drive its integral pump during surgery to provide a pulsatile jet of sterile fluid (typically saline) to irrigate, wash, and evacuate debris from general soft-tissue and orthopaedic surgical sites. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FQH	Lavage, Jet

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ec8f74ae-a6dc-42f9-a126-3dfe9f91574a
Public Version Date: March 31, 2021
Public Version Number: 3
DI Record Publish Date: April 02, 2019

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

[?]

Phone: +41628238800
Email: info@medaxis.ch

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