FDA.reportPublic FDA data

VIPER

Primary DI
10705034123271
Brand
VIPER
Company
Medos International Sàrl
Model
186717530
Catalog number
186717530
Device description
VIPER SYSTEM CANNULATED MONOAXIAL SCREW 5.5 x 5.0 x 30mm
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034123271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503412327110705034123271

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034165448COUGAR1891555141891555142015-09-24
10705034189017VG22733401002733401002016-12-31
10705034192802SUMMIT2746280002746280002016-12-31
10705034195278DISCOVERY2757200002757200002016-12-31
10705034199368EXPEDIUM2797224602797224602016-12-31
10705034224817UNIPLATE2897110002897110002016-12-31
10705034204246KEYSTONE2821040002821040002016-11-18
10705034060835BENGAL1773061221773061222015-09-24
10705034060866BENGAL1773061281773061282015-09-24
10705034161372COUGAR1891304101891304102015-09-24
10705034162973COUGAR1891404141891404142015-09-24
10705034163345COUGAR1891408121891408122015-09-24
10705034163369COUGAR1891408141891408142015-09-24
10705034163383COUGAR1891408161891408162015-09-24
10705034163499COUGAR1891451141891451142015-09-24
10705034163581COUGAR1891452101891452102015-09-24
10705034163604COUGAR1891452121891452122015-09-24
10705034163628COUGAR1891452141891452142015-09-24
10705034164168COUGAR1891458161891458162015-09-24
10705034164212COUGAR1891501081891501082015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNH2026-05-25
00763000887070CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108141RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108158RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108165RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108172RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108189RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108196RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108202RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108219RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732108226RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732122529RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732122536RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732131835RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732145085RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732145092RAPHAEL Pedicle Screw SystemCTL Medical CorporationMNH2024-01-04
00841732117860PICASSO IICTL Medical CorporationMNH2023-09-07
00841732117877PICASSO IICTL Medical CorporationMNH2023-09-07
00841732117884PICASSO IICTL Medical CorporationMNH2023-09-07
00841732117891PICASSO IICTL Medical CorporationMNH2023-09-07
00841732117907PICASSO IICTL Medical CorporationMNH2023-09-07
00841732117914PICASSO IICTL Medical CorporationMNH2023-09-07
00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.MNH2018-08-17
00841732118959PICASSO IICTL Medical CorporationMNH2017-08-08
00841732118966PICASSO IICTL Medical CorporationMNH2017-08-08
00841732118973PICASSO IICTL Medical CorporationMNH2017-08-08