AccessGUDID - DEVICE: AutoPlex, VertaPlex (07613252039259)

GUDID

Device Identifier (DI) Information

Brand Name: AutoPlex, VertaPlex
Version or Model: 0607687000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0607-687-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613252039259
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 196548481 *Terms of Use

Device Description: System without Needles with HV Bone Cement

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:	Yes
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?
35217	Orthopaedic cement, non-antimicrobial	A substance designed to be used in arthroplastic and/or osteosynthetic procedures for the fixation of polymer or metallic implants to the living bone. It may also be intended for use as a filler in the case of bone pathologies (e.g., to stabilize and reinforce vertebral body structures in vertebroplasty and kyphoplasty). It is typically made from methylmethacrylate, polymethylmethacrylate (PMMA), esters of methacrylic acid or copolymers containing polymethylmethacrylate and polystyrene. This device does not contain an antimicrobial agent. After application, this device cannot be reused.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDZ	MIXER, CEMENT, FOR CLINICAL USE
PML	bone cement, posterior screw augmentation
NDN	CEMENT, BONE, VERTEBROPLASTY

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
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Temperature: between -20 and 40 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a50504d6-7fe8-4f8a-87bd-23cb3f042151
Public Version Date: March 03, 2021
Public Version Number: 6
DI Record Publish Date: January 03, 2017