AccessGUDID - DEVICE: LEVEL ONE (00888118084781)

GUDID

Device Identifier (DI) Information

Brand Name: LEVEL ONE
Version or Model: 52-400-12-04
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: KLS-Martin L.P.

Primary DI Number: 00888118084781
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 826499238 *Terms of Use

Device Description: CONTAINER, FOR XCELSIOR WATER BATH

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?
47744	Surgical water bath system	An assembly of devices designed for use within the sterile surgical field in an operating room (OR) to heat implants (typically fixation plates and screws) to make them more malleable. The assembly typically consists of a mains electricity (AC-powered) water bath with temperature-regulating controls, a thermometer/thermostats, a timer, a sterilizable water holder (a pan or a tray), and a sterility cover that is placed over the bath to maintain the integrity of the sterile surgical field. The implants are submerged in sterile water or saline solution and typically heated to approximately 60-70? Celsius.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IRQ	UNIT, HEATING, POWERED

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: bd7dd7e4-a370-4c67-91c9-95a38de67d88
Public Version Date: August 23, 2024
Public Version Number: 3
DI Record Publish Date: June 19, 2020

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

Customer Contact

[?]

Phone: +1(904)641-7746
Email: KLS-UDI-Info@klsmartin.com

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