AccessGUDID - DEVICE: ReActiv8 Torque Wrench (05391527770817)

GUDID

Device Identifier (DI) Information

Brand Name: ReActiv8 Torque Wrench
Version or Model: 7M5500-002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 5500
Company Name: MAINSTAY MEDICAL LIMITED

Primary DI Number: 05391527770817
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 985519015 *Terms of Use

Device Description: Torque Wrench (packaged as a standalone accessory)

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?
32871	Surgical torque wrench, reusable	A hand-held manual surgical instrument intended to be used for gripping, turning/tightening, or twisting an object (e.g., a nut, bolt, or wire) during a surgical intervention; it is not dedicated to dental use only. It may be available in a variety of forms and might have fixed or adjustable jaws, or a detachable endpiece(s) [e.g., ratchet type]. This is a reusable device.	Active	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: 63f80b45-bca5-4ae0-86d9-420eba6a4ad9
Public Version Date: February 02, 2021
Public Version Number: 1
DI Record Publish Date: January 25, 2021