4CIS SARA SPINE SYSTEM 1019-7055

GUDID 00840185302410

Mono-axial Pedicle Screw, Ø7.0 mm , 55 mm Length

SOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00840185302410
NIH Device Record Key3d2a3f80-f24f-4873-9f75-e22b9c57c465
Commercial Distribution StatusIn Commercial Distribution
Brand Name4CIS SARA SPINE SYSTEM
Version Model NumberAISP-1019-7055
Catalog Number1019-7055
Company DUNS868354728
Company NameSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITED
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840185302410 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

[00840185302410]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-05
Device Publish Date2021-03-26

On-Brand Devices [4CIS SARA SPINE SYSTEM]

00840185314598Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 100 mm Length
00840185314581Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 95 mm Length
00840185314574Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 90 mm Length
00840185314567Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 85 mm Length
00840185314550Poly-axial Reduction Pedicle Screw, Ø7.5 mm , 80 mm Length
00840185314543Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 100 mm Length
00840185314536Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 95 mm Length
00840185314529Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 90 mm Length
00840185314512Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 85 mm Length
00840185314505Poly-axial Reduction Pedicle Screw, Ø7.0 mm , 80 mm Length
00840185314499Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 100 mm Length
00840185314482Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 95 mm Length
00840185314475Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 90 mm Length
00840185314468Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 85 mm Length
00840185314451Poly-axial Reduction Pedicle Screw, Ø6.5 mm , 80 mm Length
00840185311085Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 100
00840185311078Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 95
00840185311061Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 90
00840185311054Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 85
00840185311047Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 80
00840185311030Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 75
00840185311023Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 70
00840185311016Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 65
00840185311009Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 60
00840185310996Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 55
00840185310989Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 50
00840185310972Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 45
00840185310965Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 40
00840185310958Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.5 mm, Length mm : 35
00840185310927Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 100
00840185310910Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 95
00840185310903Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 90
00840185310897Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 85
00840185310880Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 80
00840185310873Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 75
00840185310866Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 70
00840185310859Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 65
00840185310842Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 60
00840185310835Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 55
00840185310828Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 50
00840185310811Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 45
00840185310804Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 40
00840185310798Mono-axial Reduction Cannulated Pedicle Screw, Ø 7.0 mm, Length mm : 35
00840185310767Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 100
00840185310750Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 95
00840185310743Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 90
00840185310736Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 85
00840185310729Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 80
00840185310712Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, Length mm : 75
00840185310705Mono-axial Reduction Cannulated Pedicle Screw, Ø 6.5 mm, 70 mm Length
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