AccessGUDID - DEVICE: Vu aPod™

GUDID

Device Identifier (DI) Information

Brand Name: Vu aPod™ - L
Version or Model: 31-40-0026
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31-40-0026
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981117870
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Lateral implant insertion slide

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:	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?
35315	Orthopaedic retractor	A hand-held manual surgical instrument designed to separate and/or draw back tissues to permit access to skeletal structures for examination or intervention. It is made of high-grade stainless steel. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 5d5dc527-8346-4e5e-8394-036482ac2cc0
Public Version Date: December 30, 2024
Public Version Number: 3
DI Record Publish Date: May 02, 2016