FDA.reportPublic FDA data

VIPER PRIME

Primary DI
10705034507729
Brand
VIPER PRIME
Company
Medos International Sàrl
Model
286750082
Catalog number
286750082
Device description
VIPER PRIME COMPRESSOR DRIVER LEG
Published
2017-05-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWNINSTRUMENT, COMPRESSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWNInstrument, CompressionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034507729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503450772910705034507729

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate tensionerA hand-held manual surgical instrument designed to apply tension to an orthopaedic implant (typically a fixation plate) to compress a fracture site prior to final fixation of the implant. It is typically designed with two adjustable legs, one terminating with an anchoring loop that is attached to intact bone and the other terminating with a claw that is attached to the implant which has been fixed to one side of the fracture site; after device placement the fracture is compressed through manual operation of a device mechanism (e.g., turning a central screw). It is typically made of high-grade stainless steel and may be used on simple or compound fractures. This is a reusable device.

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886705002085BIOKNOTLESS ORTHOCORD ETHIBOND2127222127222015-09-01
10886705002122BIOKNOTLESS ORTHOCORD ETHIBOND2127262127262015-09-01
10886705007530HEALIX PEEK ORTHOCORD2222052222052015-09-01
10886705007554HEALIX PEEK ORTHOCORD2222072222072015-09-01
10886705007578HEALIX PEEK ORTHOCORD2222092222092015-09-01
10886705007585HEALIX PEEK ORTHOCORD2222102222102015-09-01
10886705007639HEALIX PEEK ORTHOCORD2222152222152015-09-01
10886705007677HEALIX PEEK ORTHOCORD2222192222192015-09-01
10886705007691HEALIX PEEK ORTHOCORD2222212222212015-09-01
10886705007769ORTHOCORD HEALIX BR2222292222292015-09-01
10886705007783ORTHOCORD HEALIX BR2222322222322015-09-01
10886705007790ORTHOCORD HEALIX BR2222332222332015-09-01
10886705007844ORTHOCORD HEALIX BR2222382222382015-09-01
10886705007851ORTHOCORD HEALIX BR2222392222392015-09-01
10886705013616INTRAFIX2546802546802015-09-01
10886705013623INTRAFIX2546812546812015-09-01
10886705013630INTRAFIX2546822546822015-09-01
10886705013647INTRAFIX2546832546832015-09-01
10886705013654INTRAFIX2546842546842015-09-01
10886705013661INTRAFIX2546852546852015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982357335VOLTSynthes GmbHHWN2026-09-25
10886982357342VOLTSynthes GmbHHWN2026-09-25
10886982357359VOLTSynthes GmbHHWN2026-09-25
10886982357366VOLTSynthes GmbHHWN2026-09-25
10886982357373VOLTSynthes GmbHHWN2026-09-25
10886982357380VOLTSynthes GmbHHWN2026-09-25
10886982357397VOLTSynthes GmbHHWN2026-09-25
10886982357403VOLTSynthes GmbHHWN2026-09-25
10886982357410VOLTSynthes GmbHHWN2026-09-25
10886982357427VOLTSynthes GmbHHWN2026-09-25
10886982357434VOLTSynthes GmbHHWN2026-09-25
10886982357441VOLTSynthes GmbHHWN2026-09-25
10886982357458VOLTSynthes GmbHHWN2026-09-25
10886982357465VOLTSynthes GmbHHWN2026-09-25
10886982357472VOLTSynthes GmbHHWN2026-09-25
10886982357489VOLTSynthes GmbHHWN2026-09-25
10886982357823VOLTSynthes GmbHHWN2026-09-25
10886982357830VOLTSynthes GmbHHWN2026-09-25
00850083430009SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430047SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430078SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00850083430092SOLOFIX Provisional Fixation SystemAXIA ORTHOPEDICS, INC.HWN2026-08-17
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.HWN2026-07-17
00840311251148Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251155Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251162Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251179Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311251377Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-30
00840311262953Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HWN2026-04-27