FOCUS

GUDID 00810005662550

Pedicle screw cross connect holder Class 1 instrument. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.

NVISION BIOMEDICAL TECHNOLOGIES, INC.

General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit General internal orthopaedic fixation system implantation kit
Primary Device ID00810005662550
NIH Device Record Keyb4967b7f-ce15-428d-8426-215920b6aa22
Commercial Distribution StatusIn Commercial Distribution
Brand NameFOCUS
Version Model NumberPD-1000T-113
Company DUNS047486041
Company NameNVISION BIOMEDICAL TECHNOLOGIES, INC.
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com
Phone210-545-3713
Emaildiana@nvisionbiomed.com

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.
Special Storage Condition, SpecifyBetween 0 and 0 *A complete case with devices and instruments should not exceed 25 lbs filled, and should not be stacked at any time.

Device Identifiers

Device Issuing AgencyDevice ID
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]
GS100810005662550 [Primary]

FDA Product Code

MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use
MDMInstrument, Manual, Surgical, General Use

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


[00810005662550]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-30
Device Publish Date2020-07-22

On-Brand Devices [FOCUS]

00814008029822Tower Dis-Engage Instrument. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029815Small Ratcheting T-Handle. The FOCUS Pedicle Screw System is intended for use in the non-cervic
00814008029754Cross Connector Screw Driver. The FOCUS Pedicle Screw System is intended for use in the non-cer
00814008029747Rod Template. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior
00814008029730Rod, MIS, Lordotic 5.5X130mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
00814008029723Rod, MIS, Lordotic 5.5X120mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
00814008029716Rod, MIS, Lordotic 5.5X110mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
00814008029709Rod, MIS, Lordotic 5.5X100mm. The FOCUS Pedicle Screw System is intended for use in the non-cer
00814008029693Rod, MIS, Lordotic 5.5X90mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029686Rod, MIS, Lordotic 5.5X80mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029679Rod, MIS, Lordotic 5.5X70mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029662Rod, MIS, Lordotic 5.5X65mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029655Rod, MIS, Lordotic 5.5X60mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029648Rod, MIS, Lordotic 5.5X55mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029631Rod, MIS, Lordotic 5.5X50mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029624Rod, MIS, Lordotic 5.5X45mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029617Rod, MIS, Lordotic 5.5X40mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029600Rod, MIS, Lordotic 5.5X35mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029594Rod, MIS, Lordotic 5.5X30mm. The FOCUS Pedicle Screw System is intended for use in the non-cerv
00814008029587PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X110mm. The FOCUS Pedicle Screw System is inte
00814008029570PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X105mm. The FOCUS Pedicle Screw System is inte
00814008029563PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X100mm. The FOCUS Pedicle Screw System is inte
00814008029556PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X95mm. The FOCUS Pedicle Screw System is inten
00814008029549PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X90mm. The FOCUS Pedicle Screw System is inten
00814008029532PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X85mm. The FOCUS Pedicle Screw System is inten
00814008029525PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X80mm. The FOCUS Pedicle Screw System is inten
00814008029518PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X75mm. The FOCUS Pedicle Screw System is inten
00814008029501PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X70mm. The FOCUS Pedicle Screw System is inten
00814008029495PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X65mm. The FOCUS Pedicle Screw System is inten
00814008029488PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X60mm. The FOCUS Pedicle Screw System is inten
00814008029471PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X55mm. The FOCUS Pedicle Screw System is inten
00814008029464PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X50mm. The FOCUS Pedicle Screw System is inten
00814008029457PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X45mm. The FOCUS Pedicle Screw System is inten
00814008029440PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X40mm. The FOCUS Pedicle Screw System is inten
00814008029433PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X35mm. The FOCUS Pedicle Screw System is inten
00814008029426PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X30mm. The FOCUS Pedicle Screw System is inten
00814008029419PS, MIS-Tower Reduction, Cannulated Dual Lead 8.5X25mm. The FOCUS Pedicle Screw System is inten
00814008029402PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X60mm. The FOCUS Pedicle Screw System is inten
00814008029396PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X55mm. The FOCUS Pedicle Screw System is inten
00814008029389PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X50mm. The FOCUS Pedicle Screw System is inten
00814008029372PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X45mm. The FOCUS Pedicle Screw System is inten
00814008029365PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X40mm. The FOCUS Pedicle Screw System is inten
00814008029358PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X35mm. The FOCUS Pedicle Screw System is inten
00814008029341PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X30mm. The FOCUS Pedicle Screw System is inten
00814008029334PS, MIS-Tower Reduction, Cannulated Dual Lead 7.5X25mm. The FOCUS Pedicle Screw System is inten
00814008029327PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X60mm. The FOCUS Pedicle Screw System is inten
00814008029310PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X55mm. The FOCUS Pedicle Screw System is inten
00814008029303PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X50mm. The FOCUS Pedicle Screw System is inten
00814008029297PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X45mm. The FOCUS Pedicle Screw System is inten
00814008029280PS, MIS-Tower Reduction, Cannulated Dual Lead 6.5X40mm. The FOCUS Pedicle Screw System is inten

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