AccessGUDID - DEVICE: Lordotic Trial Sizer 16x14, H11mm (B806RO1447L21116X140)

GUDID

Device Identifier (DI) Information

Brand Name: Lordotic Trial Sizer 16x14, H11mm
Version or Model: RO1447L21116X14
Commercial Distribution Status: In Commercial Distribution
Catalog Number: RO1447L21116X14
Company Name: Spineup, Inc.

Primary DI Number: B806RO1447L21116X140
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 116999578 *Terms of Use

Device Description: Lordotic Trial Sizer 16x14, H11mm

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?
44788	Spinal implant trial	A copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWT	Template

FDA Premarket Submission

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

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
No Device Sizes

Device Record Status

Public Device Record Key: e2da01b2-53e0-45f5-96f9-348f9643e1b4
Public Version Date: October 04, 2024
Public Version Number: 1
DI Record Publish Date: September 26, 2024