FDA.reportPublic FDA data

Mastel Surgical

Primary DI
00642356005058
Brand
Mastel Surgical
Company
Mastel Surgical Inc.
Model
KWR-600
Device description
"K-WIRE/STEINMANN PIN RACK, 6"" 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
00642356005058PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00642356005058006423560050586423560050580642356005058

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
00642356005812SteriBestCP471D1-SBAT01552026-07-28
00642356005645SteriBest44-0218122026-07-22
00642356002972SteriBestCP1038D1-SB80.CP1038D1-SB2025-11-06
00642356003009SteriBestCP1038D2-SB80.CP1038D2-SB2025-11-06
00642356003016SteriBestCP1038S-SB80.CP1038S-SB2025-11-06
00642356003023SteriBestCP471D1-SB80.CP471D1-SB2025-11-06
00642356003054SteriBestCP471S-SB80.CP471S-SB2025-11-06
00642356003108SteriBestCP614-SB80.CP614-SB2025-11-06
00642356003146SteriBestCP634-SB80.CP634-SB2025-11-06
00642356003160SteriBestCP778-SB80.CP778-SB2025-11-06
00642356005041Mastel SurgicalKWR-4002026-04-13
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
00642356002989SteriBestCP1038D1-P-1S/L80.CP1038D1-P-1S/L2025-11-06
00642356002996SteriBestCP1038D1-P-3S/L80.CP1038D1-P-3S/L2025-11-06
00642356003030SteriBestCP471D1-P-1S/L80.CP471D1-P-1S/L2025-11-06
00642356003047SteriBestCP471D1-P-3S/L80.CP471D1-P-3S/L2025-11-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
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00724995296322V. MuellerSteris CorporationFSM2026-08-21
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00724995296414V. MuellerSteris CorporationFSM2026-08-21
00724995296421V. MuellerSteris CorporationFSM2026-08-21
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