AccessGUDID - DEVICE: ReActiv8 IPG (05391527770015)

GUDID

Device Identifier (DI) Information

Brand Name: ReActiv8 IPG
Version or Model: 7M5100-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5100
Company Name: MAINSTAY MEDICAL LIMITED

Primary DI Number: 05391527770015
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985519015 *Terms of Use

Device Description: ReActiv8 Implantable Pulse Generator

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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:	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?
62422	Implantable lumbar neuromuscular electrical stimulation system pulse generator	A sterile, implantable, electronic component of an implantable lumbar neuromuscular electrical stimulation system intended to deliver episodic electrical stimulation to nerves that innervate lumbar muscles to elicit contraction for the treatment of chronic low back pain (CLBP). It is a battery-powered electrical pulse generator, typically implanted in a subcutaneous pocket in the low back region, which has connections for electrical leads (not included). The device is programmed, controlled and charged telemetrically by external devices.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
QLK	Stimulator, Neuromuscular, Lower Back Muscles, Totally Implanted For Pain Relief

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P190021	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
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: e318cb7d-6145-4530-a634-987d8381d0ef
Public Version Date: February 02, 2021
Public Version Number: 1
DI Record Publish Date: January 25, 2021

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: 877-702-8488
Email: info@mainstay-medical.com

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