FDA.report

REVERE

Primary DI
00849044054873
Brand
REVERE
Company
GLOBUS MEDICAL, INC.
Model
524.565
Device description
5.5mm Straight Rod, Hex-End, 65mm
Published
2015-11-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00849044054873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00849044054873008490440548738490440548730849044054873

GMDN Terms

TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

Device Sizes

TypeValueUnit
Length65Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags

DUNS number
139105691
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00193982647667ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.37202026-02-10
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00193982647681ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6181.50222026-02-10
00889095305401COALITION MIS6136.10032016-10-11
00193982534011ANTHEM1181.82022026-01-27
00193982534028ANTHEM1181.82032026-01-27
00193982534035ANTHEM1181.82042026-01-27
00193982534042ANTHEM1181.82052026-01-27
00193982534059ANTHEM1181.82062026-01-27
00193982534066ANTHEM1181.82072026-01-27
00193982534073ANTHEM1181.82082026-01-27

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Primary DIBrandCompanyProduct codePublished
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00763000887162CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
088000333582064CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2020-03-26
088000333846944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847554CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333847864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2016-10-28
088000333850974CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333851104CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-12-11
088000333859984CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860184CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860494CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860564CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860634CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860704CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860874CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333860944CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861004CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861174CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861244CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861314CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861484CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861624CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861794CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24
088000333861864CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNI2015-09-24