AccessGUDID - DEVICE: StimRouter Clinician's Kit (00815962020023)

GUDID

Device Identifier (DI) Information

Brand Name: StimRouter Clinician's Kit
Version or Model: ST2-4000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIONESS INC.

Primary DI Number: 00815962020023
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 182287727 *Terms of Use

Device Description: Clinician’s Programmer with Software

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
60960	Analgesic PENS system probe, single-use	A sterile, hand-held electrical conductor intended to be used as part of an analgesic percutaneous electrical nerve stimulation (PENS) system to deliver controlled electrical impulses directly to subcutaneous tissue for the relief of chronic neuropathic pain. It is intended to be connected to an analgesic PENS system generator and its conductive length introduced percutaneously (invasively) into the patient, in the vicinity of a peripheral nerve. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZF	STIMULATOR, PERIPHERAL NERVE, IMPLANTED (PAIN RELIEF)

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: b7a11ed8-7906-4d14-8da1-c0f440483ee1
Public Version Date: September 20, 2021
Public Version Number: 5
DI Record Publish Date: December 19, 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: 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: Yes
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)211-9136
Email: info@bioness.com

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