AccessGUDID - DEVICE: Accu Spina / Spina System Cervical (00869444000218)

GUDID

Device Identifier (DI) Information

Brand Name: Accu Spina / Spina System Cervical
Version or Model: 21
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: NORTH AMERICAN MEDICAL CORPORATION

Primary DI Number: 00869444000218
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 031023091 *Terms of Use

Device Description: Physiotherapeutic treament device

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?
45537	Static/intermittent powered traction system, non-mobile	An assembly of devices capable of applying continuous and various intermittent (regular, progressive/regressive, cycled) traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of an AC-powered motor with a control unit used to generate and regulate the mechanical forces, and a cord clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used primarily to widen intervertebral spaces.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ITH	Equipment, Traction, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K033231	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
Handling Environment Temperature: between 0 and 50 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 128 Inch
Width: 58 Inch
Height: 88 Inch

Device Record Status

Public Device Record Key: df6ba08c-8bf6-4e9d-91fc-594ae3d9a749
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016