AccessGUDID - DEVICE: RecoverPad (00851610008289)

GUDID

Device Identifier (DI) Information

Brand Name: RecoverPad
Version or Model: REPSHS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: REPSHS
Company Name: SAUVRE INTERNATIONAL, LTD.

Primary DI Number: 00851610008289
Issuing Agency: GS1
Commercial Distribution End Date: September 17, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 080557421 *Terms of Use

Device Description: Transcutaneous electrical stimulation electrode, Hand shape, 50x78mm

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):	Yes
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?
35995	Transcutaneous electrical stimulation electrode, single-use	An electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GXY	Electrode, Cutaneous

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
Storage Environment Temperature: less than 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 78 Millimeter
Width: 50 Millimeter

Device Record Status

Public Device Record Key: 7cb6cd7b-878f-4a19-a878-8badf36665fd
Public Version Date: February 19, 2021
Public Version Number: 5
DI Record Publish Date: January 08, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
10851610008309	80	00851610008302	2020-09-17	Not in Commercial Distribution	Box
00851610008302	20	00851610008289	2020-09-17	Not in Commercial Distribution	Bag
10851610008293	120	00851610008296	2020-09-17	Not in Commercial Distribution	Box
00851610008296	10	00851610008289	2020-09-17	Not in Commercial Distribution	Bag