AccessGUDID - DEVICE: Orantech (06941691946113)

GUDID

Device Identifier (DI) Information

Brand Name: Orantech
Version or Model: EKA-LCA-A
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Orantech Inc.

Primary DI Number: 06941691946113
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 544423370 *Terms of Use

Device Description: Limb Clamp Electrode Color white/green/red/black,Adult, AHA, 4pcs/Set

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:	No
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?
63118	Multi-purpose invasive/noninvasive electrode kit	A collection of dedicated electrodes intended to support a variety of electrophysiological measurements [e.g., electrocardiography (ECG), electroencephalography (EEG), electromyography (EMG), intraoperative monitoring (IOM), evoked potentials (EP)]. It includes both invasive (e.g., subdermal needle electrode) and noninvasive (i.e. skin surface) electrodes, and may include electrodes intended for stimulation; at least one reusable electrode is included. Supportive devices such as leads and adaptors may be included, however it does not include any monitors/monitoring devices. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, Electrocardiograph

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: 3f3abf9e-722b-4e88-ba6c-eab8ce501b78
Public Version Date: May 08, 2023
Public Version Number: 2
DI Record Publish Date: September 20, 2022

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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