BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

AutoPlex, VertaPlex

DI: 07613154687169 · Model: 0605687000 · STRYKER CORPORATION

View on AccessGUDID

Product Codes

2

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

Let the assistant research this device

The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Brand Name: AutoPlex, VertaPlex
Primary DI: 07613154687169
Version / Model: 0605687000
Catalog Number: 0605-687-000
Company Name: STRYKER CORPORATION
Labeler DUNS: 196548481
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2016-12-29
Public Version: 5
Public Version Date: 2019-08-01
Public Version Status: Update
Public Device Record Key: 87cf83b8-134f-4032-b7ff-2577669f7381

Device Description

System without Needles with Bone Cement

Device Characteristics

Single Use: Yes
Prescription Use (Rx): Yes
Over the Counter (OTC): No
Kit: Yes
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: No
Has Serial Number: No
Has Lot/Batch Number: Yes
Has Manufacturing Date: No
Has Expiration Date: Yes
Has Donation ID: No

Sterilization

Is Sterile: Yes
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LOD	BONE CEMENT	Orthopedic	888.3027	2
JDZ	MIXER, CEMENT, FOR CLINICAL USE	Orthopedic	888.4210	1

GMDN Terms

Code	Name	Definition	Implantable	Status
47742	Orthopaedic cement mixing container, single-use	A sterile device in which an orthopaedic cement dispenser is intended to be placed to maintain the sterility of the dispenser and its contents (orthopaedic cement) when it is taken out of the sterile field to be mixed by an automatic mixer during a surgical procedure. It is typically made of plastic material and designed to be passed by operating staff from the sterile field to staff who may not be sterile, and back again, without compromising the sterility of its contents. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	37613154687160	GS1	pack	2	In Commercial Distribution
Primary	07613154687169	GS1

Customer Contacts

Phone: +1(800)253-3210
Email: [email protected]

Storage Conditions

Type: Handling Environment Humidity
Temperature Range: 10 – 75 Percent (%) Relative Humidity
Type: Handling Environment Temperature
Temperature Range: -20 – 40 Degrees Celsius