Polyaxial screw reduct., w/o cannulation 7.5mm/60mm

Basic Information

• Brand Name: Polyaxial screw reduct., w/o cannulation 7.5mm/60mm
• Primary DI: EMAHPSR1175600
• Version / Model: PSR11-7560
• Catalog Number: PSR11-7560
• Company Name: mahe medical gmbh
• Labeler DUNS: 342243334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-08-04
• Public Version: 2
• Public Version Date: 2018-03-29
• Public Version Status: Update
• Public Device Record Key: 58a336ba-44f5-476c-a4f2-12f80cabd222

Device Description

Polyaxial screw reduct., w/o cannulation 7.5mm/60mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• 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: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NKB	Orthosis, spinal pedicle fixation, for degenerative disc disease	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61325	Bone-screw internal spinal fixation system, non-sterile	An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EMAHPSR1175601	HIBCC		1	In Commercial Distribution
Primary	EMAHPSR1175600	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	60.0	Millimeter
Outer Diameter	7.5	Millimeter

Storage Conditions

• Type: Storage Environment Humidity
• Temperature Range: 10 – 50 Percent (%) Relative Humidity
• Type: Special Storage Condition, Specify
• Special Conditions: cool,dry,dark
• Type: Storage Environment Temperature
• Temperature Range: 10 – 28 Degrees Celsius