FDA.reportPublic FDA data

LEVEL ONE

Primary DI
00888118124197
Brand
LEVEL ONE
Company
KLS-Martin L.P.
Model
25-490-21-07
Published
2019-12-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FZTCUTTER, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZTCutter, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118124197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118124197008881181241978881181241970888118124197

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantable-device cutterA heavy-duty manual surgical instrument designed to hold and cut orthopaedic surgical implant devices (i.e., metal rods, plates, screws). The cutting is typically performed with a shearing action. It may be a hand-held or a table mounted device. 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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
03662663129053Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCFZT2026-02-11
10889981087968GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087975GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981087982GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981095970GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981106058CoralSeaspine Orthopedics CorporationFZT2025-12-19
10889981123932GeneralSeaspine Orthopedics CorporationFZT2025-12-19
10889981259921NorthStarSeaspine Orthopedics CorporationFZT2025-12-19
03662663278096Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-18
03662663217699Vail OCT Spinal Fixation SystemHighridge Medical, LLCFZT2025-12-17
03662663266635Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266642Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266659Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266666Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266673Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266680Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266697Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266703Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266710Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266727Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266734Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266741Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266758Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266765Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663266772Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278799Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278805Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278812Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278829Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16
03662663278836Timberline Lateral Fusion SystemHighridge Medical, LLCFZT2025-12-16