AccessGUDID - DEVICE: VertaPlex HV (07613327170559)

GUDID

Device Identifier (DI) Information

Brand Name: VertaPlex HV
Version or Model: 0406622015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0406-622-015
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327170559
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: 20 Gram Twin Pack (1/2 dose)

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?
60505	Vertebral bone filler, non-bioabsorbable	A sterile substance intended to be used to replace cortical/cancellous bone in a vertebral body to stabilize vertebral compression fractures (VCFs) caused by cancer, osteoporosis, or trauma. The device may be a sterile powder of a synthetic polymer [e.g., polymethylmethacrylate (PMMA)] that is mixed with its sterile diluent, or a non-PMMA-containing elastomer formed by mixing two precursors, prior to implantation typically during a balloon kyphoplasty or vertebroplasty procedure. This device does not contain an antibiotic agent. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
NDN	CEMENT, BONE, VERTEBROPLASTY
PML	bone cement, posterior screw augmentation
NKB	Thoracolumbosacral pedicle screw system
LON	SYSTEM, TEST, AUTOMATED, ANTIMICROBIAL SUSCEPTIBILITY, SHORT INCUBATION
MNI	Orthosis, spinal pedicle fixation

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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: 3eae6a82-d778-432c-90bb-68a4eb4add9d
Public Version Date: May 09, 2025
Public Version Number: 4
DI Record Publish Date: September 23, 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
57613327170554	22	07613327170559		In Commercial Distribution	case

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

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: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +0018002533210
Email: INST.STRYKER.CS@STRYKER.COM

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