AccessGUDID - DEVICE: SPRINT (00850022775291)

GUDID

Device Identifier (DI) Information

Brand Name: SPRINT
Version or Model: 50009
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 50009
Company Name: SPR THERAPEUTICS, INC.

Primary DI Number: 00850022775291
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963383778 *Terms of Use

Device Description: Clinical Programmer Software

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?
60959	Analgesic PENS system	An assembly of mains electricity (AC-powered) devices intended for the relief of chronic neuropathic pain through percutaneous electrical nerve stimulation (PENS). It typically consists of external current generator, return electrode(s), connection cables and a system probe which may be provided separately. It is intended to deliver controlled electrical impulses directly to the subcutaneous tissue (i.e., invasively) in the vicinity of a peripheral nerve. It is intended to be used by a healthcare professional in a clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NHI	Stimulator, Nerve, Electrical, Percutaneous (Pens), For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K223306	000

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: d50eef29-1911-45dc-abf8-13fb9acd7198
Public Version Date: April 24, 2023
Public Version Number: 1
DI Record Publish Date: April 14, 2023

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: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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