FDA.reportPublic FDA data

Virage® OCT

Primary DI
00887868289385
Brand
Virage® OCT
Company
ZIMMER BIOMET INC
Model
07.01803.001
Catalog number
07.01803.001
Published
2020-02-13
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
HXPINSTRUMENT, BENDING OR CONTOURING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXPInstrument, Bending Or ContouringOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868289385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868289385008878682893858878682893850887868289385

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com
+1(866)774-6368zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
045576443
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480511557Lineum®14-52505314-5250532020-07-07
00887868289163Virage® OCT07.01770.00107.01770.0012020-02-13
00887868289170Virage®07.01771.00207.01771.0022020-02-13
00887868289187Virage®07.01772.00207.01772.0022020-02-13
00887868289194Virage®07.01773.00207.01773.0022020-02-13
00887868244728Vital™730M0011730M00112019-06-04
00887868244735Vital™730M0012730M00122019-06-04
03662663063081Vital Spinal Fixation System710M11562024-06-26
03662663063098Vital Spinal Fixation System710M12562024-06-26
03662663063104Vital Spinal Fixation System710M13562024-06-26
03662663063111Vital Spinal Fixation System710M14562024-06-26
03662663063128Vital Spinal Fixation System710M15562024-06-26
03662663063135Vital Spinal Fixation System710M17562024-06-26
00887868528774VItal Spinal Fixation System850M00302024-06-11
00887868528781VItal Spinal Fixation System850M00312024-06-11
00887868528798VItal Spinal Fixation System850M00322024-06-11
00887868528804VItal Spinal Fixation System850M00332024-06-11
00887868528811VItal Spinal Fixation System850M00342024-06-11
00887868528828VItal Spinal Fixation System850M00352024-06-11
00887868528866VItal Spinal Fixation System850M00352024-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569620479Newclip InstrumentsNEWCLIP TECHNICSHXP2026-05-07
00840311262960Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.HXP2026-04-27
00199150066919Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2026-03-02
07640187463149Bending Iron SmallBonebridge AGHXP2026-01-16
07640187463156Bending Plier SmallBonebridge AGHXP2026-01-16
07640187463163Cutting PlierBonebridge AGHXP2026-01-16
00199150029464Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-10-19
M711CI1310Opteryx®INNO Holdings, Inc.HXP2025-06-30
08800071031833SignexOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697369Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809539697376Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-27
08809416068626Surgical InstrumentOSTEONIC CO.,Ltd.HXP2025-06-25
08403207010032Anmuth Medical InternationalAnmuth Medical International, LLCHXP2025-06-09
00763000987336Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2025-02-28
00841435124707TecometTECOMET INC.HXP2024-12-19
03700569652937Newclip InstrumentsNEWCLIP TECHNICSHXP2024-11-07
00763000837099CD Horizon™ ModuLeX™ Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HXP2024-10-27
10886982335784NASynthes GmbHHXP2024-10-09
10886982335913NASynthes GmbHHXP2024-10-09
10886982336293NASynthes GmbHHXP2024-10-09
10886982336309NASynthes GmbHHXP2024-10-09
07612334236012NASynthes GmbHHXP2024-10-09
07612334236173NASynthes GmbHHXP2024-10-09
07612334236630NASynthes GmbHHXP2024-10-09
07612334236647NASynthes GmbHHXP2024-10-09
00810112597943MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
00810112597974MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHXP2024-07-31
04719878787055“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile)Paonan Biotech Co.,Ltd.HXP2024-04-15
00888233069762STERNALOCK EZBIOMET MICROFIXATION, INCHXP2024-03-25
00888515202146BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.HXP2024-02-28