AccessGUDID - DEVICE: Laminoplasty (10889981061678)

GUDID

Device Identifier (DI) Information

Brand Name: Laminoplasty
Version or Model: 52-1111
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 52-1111
Company Name: SEASPINE ORTHOPEDICS CORPORATION

Primary DI Number: 10889981061678
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: Side By Side Plate, 6mm Mouth, 11mm L

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?
57806	Vertebral body prosthesis, non-sterile	A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
NQW	ORTHOSIS, SPINE, PLATE, LAMINOPLASTY, METAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130830	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: 6mm Mouth, 11mm L

Device Record Status

Public Device Record Key: a68f9734-55b8-4e00-bdbb-35bfe526e8db
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2015