AccessGUDID - DEVICE: Valencia Pedicle Screw System (B4179090480N1)

GUDID

Device Identifier (DI) Information

Brand Name: Valencia Pedicle Screw System
Version or Model: 909-0480N
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Altus Spine, LLC

Primary DI Number: B4179090480N1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078331322 *Terms of Use

Device Description: 480mm Guide Wire, Round Tip, Nitinol

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?
62729	Orthopaedic guidewire, single-use	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a single-use device.	Active	false

FDA Product Code

[?]

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

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
Length: 480 Millimeter
Outer Diameter: 1.5 Millimeter

Device Record Status

Public Device Record Key: 80de43b3-5fdf-41ca-ab7b-ead54f144998
Public Version Date: September 11, 2024
Public Version Number: 5
DI Record Publish Date: October 28, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
GS1	00843210110233

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(610)355-4156
Email: Info@altus-spine.com

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