FDA.reportPublic FDA data

CHISEL

Primary DI
00888118026484
Brand
CHISEL
Company
KLS-Martin L.P.
Model
23-070-01-07
Device description
OSU, 3.5 MM TIP
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
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118026484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118026484008881180264848881180264840888118026484

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic chiselA hand-held, single-blade surgical instrument, bevelled on one side, designed to cut and shape bone during orthopaedic surgery. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, flat or curved [(concave) - also known as a hollow blade] in design. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). 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(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
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536017546tezoUlrich GmbH & Co. KGFZO2026-03-12
00190776417598MillenniumAvalign Technologies, Inc.FZO2026-03-04
00190776417604MillenniumAvalign Technologies, Inc.FZO2026-03-04
03662663109215Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
03662663109222Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
04058749067538NAFehling Instruments GmbH & Co. KGFZO2026-01-28
04058749075991NAFehling Instruments GmbH & Co. KGFZO2026-01-28
00190776415280MillenniumAvalign Technologies, Inc.FZO2026-01-27
00889024703872Offset Box OsteotomeZimmer, Inc.FZO2025-12-18
03662663271349Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271356Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271363Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271370Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271394Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271400Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271417Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271431Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271455Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271462Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271479Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271493Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271509Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271516Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271523Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271530Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271547Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271554Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271561Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271578Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271585Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18