FDA.reportPublic FDA data

VISE

Primary DI
00888118114402
Brand
VISE
Company
KLS-Martin L.P.
Model
50-499-00-07
Device description
BONE, MARCHAC
Published
2018-09-26
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
00888118114402PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118114402008881181144028881181144020888118114402

GMDN Terms#

Term, Definition table
TermDefinition
Bone cutting forcepsA strongly constructed, hand-held, surgical instrument used for cutting posterior rib ends and bone tissue during a surgical procedure. It typically has very strong, sharp, angled cutting blades attached to strong, sprung (self-opening), pivoted or multi-pivoted handles that, when squeezed together, close the blades so that they cut entirely through the bone. It is available in various sizes and is made of high-grade stainless steel. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
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
00888118086037SILICONE MAT55-348-01-012020-06-19
00888118125729TRAY55-804-25-012020-06-19
00888118003119CARRIER00-105-92-072018-09-26
00888118006974CURETTE01-500-01-072018-09-26
00888118006981CURETTE01-500-02-072018-09-26
00888118006998CURETTE01-500-03-072018-09-26
00888118008626CALIPER04-407-20-072018-09-26
00888118009012SCOPE HOLDER ARM07-001-42-072016-09-20
00888118009029SCOPE HOLDER CLAMP07-001-43-072016-09-20
00888118009050SCOPE HOLDER ARM07-001-49-072016-09-20
00888118022950PHLEBEXTRACTOR16-249-02-072018-09-26
00888118022967PHLEBEXTRACTOR16-249-03-072018-09-26
00888118022981STRIPPER16-251-02-012018-09-26
00888118022998STRIPPER16-251-03-012018-09-26
00888118023001STRIPPER16-251-04-012018-09-26
00888118023018STRIPPER16-251-06-012018-09-26
00888118023025STRIPPER16-251-07-012018-09-26
00888118023032STRIPPER16-251-08-012018-09-26
00888118023049STRIPPER16-251-10-012018-09-26
00888118023056STRIPPER16-251-14-012018-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD017210000Surgical DirectSurgical Direct, Inc.HXP2026-08-21
00199150074525Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HXP2026-07-19
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