AccessGUDID - DEVICE: Dymaxeon® (00815500020836)

GUDID

Device Identifier (DI) Information

Brand Name: Dymaxeon®
Version or Model: 06.0
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 06.3405B
Company Name: BACK 2 BASIC DIRECT, LLC

Primary DI Number: 00815500020836
Issuing Agency: GS1
Commercial Distribution End Date: February 14, 2019
Device Count: 2
Labeler D-U-N-S® Number*: 043841348 *Terms of Use

Device Description: DYMAXEON OPEN POLYAXIAL PEDICULAR SCREW Ø7.5 x70mm (VIOLET)

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:	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?
61324	Bone-screw internal spinal fixation system, sterile	An assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
MNH	Orthosis, spondylolisthesis spinal fixation
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121786	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
Special Storage Condition, Specify: devices kept at room temperature or other standard conditions
Storage Environment Temperature: less than 86 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Length: 70 Millimeter

Device Record Status

Public Device Record Key: ffb0c181-482d-4127-b136-764a2e422f12
Public Version Date: February 15, 2019
Public Version Number: 4
DI Record Publish Date: January 15, 2016