FDA.reportPublic FDA data

LEVEL ONE SMALL BONE

Primary DI
00888118132680
Brand
LEVEL ONE SMALL BONE
Company
KLS-Martin L.P.
Model
26-875-06-07
Device description
DEPTH GAUGE, HBS 2, 2.5 MM
Published
2026-04-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118132680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118132680008881181326808881181326800888118132680

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). 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
00888118149244L1 THORACICCTM-24-015-84-042026-05-01
00888118149251L1 CMFCTM-55-911-83-042026-05-01
00888118149268L1 CMFCTM-55-911-84-042026-05-01
00888118149275L1 CMFCTM-55-911-85-042026-05-01
00888118149282L1 CMFCTM-55-911-86-042026-05-01
00888118149299L1 CMFCTM-55-911-87-042026-05-01
00888118149305L1 CMFCTM-55-911-88-042026-05-01
00888118149312L1 CMFCTM-55-911-89-042026-05-01
00888118149329L1 CMFCTM-55-911-90-042026-05-01
00888118126528LEVEL ONE CMF, STERILE50-774-24-712020-04-22
00888118006530LEVEL ONE CMF01-405-08-092016-03-24
00888118034717LEVEL ONE CMF25-001-13-092016-03-24
00888118034731LEVEL ONE CMF25-002-13-092016-03-24
00888118034748LEVEL ONE CMF25-003-02-092016-03-24
00888118034816LEVEL ONE NEURO, STERILE25-003-10-712016-03-23
00888118034915LEVEL ONE NEURO25-003-21-092016-03-24
00888118035028LEVEL ONE NEURO25-005-12-092016-03-24
00888118035042LEVEL ONE CMF25-006-09-092016-03-24
00888118035721LEVEL ONE CMF25-010-03-092016-03-24
00888118035752LEVEL ONE CMF25-010-08-092016-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
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08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
08800071006862Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
08809539690667Surgical InstrumentOSTEONIC CO.,Ltd.HTJ2025-06-24
10840199512703Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10840199513670Multi Level Black Belt Depth GaugeKOROS U.S.A., INC.HTJ2024-12-31
10885862573483EPICExactech, Inc.HTJ2024-01-08
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374561DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05
10855068008331Implant Selection DeviceCURVAFIX, INC.HTJ2021-12-02
08800089415298INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
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08800089402762Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08800089402779Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
08800089402830Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2021-05-28
M684E15000401EVOLUTIONMicroport Orthopedics Inc.HTJ2019-12-23
00815362021453Slimplicity Anterior Cervical Plate SystemPRECISION SPINE, INC.HTJ2019-04-01
08806390873765VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-12-17
08806390863247Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390865869Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390867764Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-12-05
08806390857963VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28