FDA.reportPublic FDA data

Mastel Surgical

Primary DI
00642356005041
Brand
Mastel Surgical
Company
Mastel Surgical Inc.
Model
KWR-400
Device description
"K-WIRE/STEINMANN PIN RACK, 4"" WIRES"
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FSMTray, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00642356005041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356005041006423560050416423560050410642356005041

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin containerA non-sterile cylindrical device intended to temporarily hold one or more orthopaedic pin(s) [e.g., K-wires] during sterilization and a surgical procedure for protection against damage. It is made of metal (e.g., stainless steel) and is typically a cylinder with a screw top, with lateral fenestrations to enable the penetration of sterilization fluid. This is a reusable device.

Regulatory Flags#

DUNS number
789897865
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00642356005058Mastel SurgicalKWR-6002026-04-13
00642356005065Mastel SurgicalKWR-9002026-04-13
00642356004709Mastel Surgical Inc.20.110.070220.110.07022026-02-11
00642356004389SteriBest44-0207412025-12-09
00642356004396Mastel SurgicalCP1038D1-SBAT01952025-12-09
00642356004204SteriBestCP614-SBAT02102025-11-20
00642356002972SteriBestCP1038D1-SB80.CP1038D12025-11-06
00642356002989SteriBestCP1038D1-P-1S/L80.CP1038D1-P-1S/L2025-11-06
00642356002996SteriBestCP1038D1-P-3S/L80.CP1038D1-P-3S/L2025-11-06
00642356003009SteriBestCP1038D2-SB80.CP1038D22025-11-06
00642356003016SteriBestCP1038S-SB80.CP1038S2025-11-06
00642356003023SteriBestCP471D1-SB80.CP471D12025-11-06
00642356003030SteriBestCP471D1-P-1S/L80.CP471D1-P-1S/L2025-11-06
00642356003047SteriBestCP471D1-P-3S/L80.CP471D1-P-3S/L2025-11-06
00642356003054SteriBestCP471S-SB80.CP471S2025-11-06
00642356003061SteriBestCP471S-DK-280.CP471S-DK-22025-11-06
00642356003078SteriBestCP471S-DK-380.CP471S-DK-32025-11-06
00642356003085SteriBestCP471S-DK-480.CP471S-DK-42025-11-06
00642356003092SteriBestCP471S-DK-580.CP471S-DK-52025-11-06
00642356003108SteriBestCP614-SB80.CP6142025-11-06

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Primary DI, Brand, Company table
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ESAM6551101STOMA®Storz am Mark GmbHFSM2025-04-30
ESAM23080011STOMA®Storz am Mark GmbHFSM2023-06-14
ESAM6679001STOMA®Storz am Mark GmbHFSM2023-06-14
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