AccessGUDID - DEVICE: CHATTANOOGA (00888912024082)

GUDID

Device Identifier (DI) Information

Brand Name: CHATTANOOGA
Version or Model: 5000021
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DJO, LLC

Primary DI Number: 00888912024082
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 081840873 *Terms of Use

Device Description: Iogel Small 1.5 cc electrode, Box of 12

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":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	No
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?
46304	Drug-delivery iontophoresis system electrode, active	A dedicated, active, electrical conductor that is a component of an iontophoresis system for transcutaneous drug delivery of a localized medication (e.g., corticosteroids or local anaesthetics). It is typically a layered pad that is attached to the skin surface of the patient at the target site, and connected to the current generator with a lead wire. An applied electric field causes the ionic-solution medication to transport from a reservoir within the pad for patient exposure. It comes in a variety of sizes. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EGJ	Device, Iontophoresis, Other Uses
KTB	DEVICE, IONTOPHORESIS, SPECIFIC USES

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 32715f0f-3361-4a63-960c-42dd8af00e14
Public Version Date: August 23, 2024
Public Version Number: 4
DI Record Publish Date: September 24, 2014

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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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