FDA.reportPublic FDA data

Goblin Pedicle Screw System

Primary DI
00810088653155
Brand
Goblin Pedicle Screw System
Company
MEDYNUS, INC.
Model
CRT-55300
Catalog number
CRT-55300
Device description
Open CC Str 300
Published
2021-10-07
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

Product Codes#

Code, Name table
CodeName
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder Cancer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NBKSystem, Test, (Ihc), Tumor Marker, Monitoring, Bladder CancerHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810088653155PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810088653155008100886531558100886531550810088653155

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
119458950
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840354203654Impeace Cervical Plate SystemTP.PL.0110TP.PL.01102026-05-06
00840354203661Impeace Cervical Plate SystemTP.PL.0112TP.PL.01122026-05-06
00840354203678Impeace Cervical Plate SystemTP.PL.0114TP.PL.01142026-05-06
00840354203685Impeace Cervical Plate SystemTP.PL.0116TP.PL.01162026-05-06
00840354203692Impeace Cervical Plate SystemTP.PL.0118TP.PL.01182026-05-06
00840354203708Impeace Cervical Plate SystemTP.PL.0120TP.PL.01202026-05-06
00840354203715Impeace Cervical Plate SystemTP.PL.0122TP.PL.01222026-05-06
00840354203722Impeace Cervical Plate SystemTP.PL.0124TP.PL.01242026-05-06
00840354203739Impeace Cervical Plate SystemTP.PL.0126TP.PL.01262026-05-06
00840354203746Impeace Cervical Plate SystemTP.PL.0224TP.PL.02242026-05-06
00840354203753Impeace Cervical Plate SystemTP.PL.0226TP.PL.02262026-05-06
00840354203760Impeace Cervical Plate SystemTP.PL.0228TP.PL.02282026-05-06
00840354203777Impeace Cervical Plate SystemTP.PL.0230TP.PL.02302026-05-06
00840354203784Impeace Cervical Plate SystemTP.PL.0232TP.PL.02322026-05-06
00840354203791Impeace Cervical Plate SystemTP.PL.0234TP.PL.02342026-05-06
00840354203807Impeace Cervical Plate SystemTP.PL.0236TP.PL.02362026-05-06
00840354203814Impeace Cervical Plate SystemTP.PL.0238TP.PL.02382026-05-06
00840354203821Impeace Cervical Plate SystemTP.PL.0240TP.PL.02402026-05-06
00840354203838Impeace Cervical Plate SystemTP.PL.0242TP.PL.02422026-05-06
00840354203845Impeace Cervical Plate SystemTP.PL.0244TP.PL.02442026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08806162165852AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165869AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165876AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165883AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165890AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165906AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165913AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165920AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165937AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165944AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165951AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165968AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165975AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165982AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162165999AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166002AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166019AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166026AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166262AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166279AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166286AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166293AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166309AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166316AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166323AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166330AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166347AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166354AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166361AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07
08806162166378AnyPlus Spinal Fixation SystemGS Medical Co., Ltd.NBK2017-12-07