AccessGUDID - DEVICE: Apelo® / Apelo® MIS (M68120108400000)

GUDID

Device Identifier (DI) Information

Brand Name: Apelo® / Apelo® MIS
Version or Model: 2010-84-0000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2010-84-0000
Company Name: ATLAS SPINE, INC.

Primary DI Number: M68120108400000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 140801007 *Terms of Use

Device Description: MIS Torque Driver

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
47830	Surgical instrument handle, torque-limiting	A hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	Orthopedic Manual Surgical Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

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: fe6f90d9-d8fd-48ab-a2aa-4aa4fa226032
Public Version Date: September 04, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2014