AccessGUDID - DEVICE: Sierra II (00840067102022)

GUDID

Device Identifier (DI) Information

Brand Name: Sierra II
Version or Model: 190140-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: CADWELL INDUSTRIES, INC.

Primary DI Number: 00840067102022
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 098554157 *Terms of Use

Device Description: Sierra II Handheld Stim w/Optical Control

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):	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?
11474	Electromyograph	An electrically-powered unit designed for the measurement and recording of the intrinsic electrical potential of skeletal muscle for display in the form of a graph [electromyograph (EMG)], typically for diagnosis of muscle and/or nerve disorders. It is designed to receive analogue electrical signals from EMG electrodes and process/digitize these signals for viewing, either on an integrated display or for transmission to an off-the-shelf computer.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OLV	Standard polysomnograph with electroencephalograph
GWJ	STIMULATOR, AUDITORY, EVOKED RESPONSE
GWF	STIMULATOR, ELECTRICAL, EVOKED RESPONSE
JXE	DEVICE, NERVE CONDUCTION VELOCITY MEASUREMENT
IKN	Electromyograph, diagnostic
GWE	Stimulator, photic, evoked response
OLT	Non-normalizing quantitative electroencephalograph software
GWQ	Full-montage Standard Electroencephalograph

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: 73ab2413-9bc0-4ab1-a213-3365535608f4
Public Version Date: December 23, 2024
Public Version Number: 4
DI Record Publish Date: September 05, 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: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: Yes
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: No
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(509)735-6481
Email: applications@cadwell.com

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