AccessGUDID - DEVICE: Stainless Steel (10889981023218)

GUDID

Device Identifier (DI) Information

Brand Name: Stainless Steel
Version or Model: 25-14-4050
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 25-14-4050
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981023218
Issuing Agency: GS1
Commercial Distribution End Date: September 02, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Uniplanar Screw, Stainless Steel, 4.00mm x 50mm

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?
46651	Spinal bone screw, non-bioabsorbable	A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
KWQ	APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY
MNI	ORTHOSIS, SPINAL PEDICLE FIXATION
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease
MNH	Orthosis, spondylolisthesis spinal fixation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100970	000

Device Exempt from Premarket Submission: No 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
Device Size Text, specify: 4.00mm x 50mm

Device Record Status

Public Device Record Key: e0cb0587-f9d6-4c72-8725-55f6b59634d1
Public Version Date: December 30, 2024
Public Version Number: 5
DI Record Publish Date: September 24, 2015