FDA.reportPublic FDA data

LEVEL ONE TRANSBUCCAL

Primary DI
00888118075161
Brand
LEVEL ONE TRANSBUCCAL
Company
KLS-Martin L.P.
Model
50-328-01-07
Published
2018-09-26
Public version status
Update
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
HTJGAUGE, DEPTH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTJGauge, DepthOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118075161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118075161008881180751618881180751610888118075161

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
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
00199150076192Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HTJ2026-05-23
08809945895076EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-03-23
00810111225649Depth GageTreace Medical Concepts, Inc.HTJ2026-03-19
10885862661449N/AExactech, Inc.HTJ2026-03-19
00840124525450Depth GaugeFUSION ORTHOPEDICS, LLCHTJ2026-03-06
08809945895021EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895038EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895045EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895052EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895069EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895083EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895090EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895106EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
08809945895113EXULT Surgical InstrumentCorentec Co., LtdHTJ2026-02-20
00810112597486TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2026-02-10
06438394001534Activa InstrumentBioretec OyHTJ2026-01-30
06438394001541Activa InstrumentBioretec OyHTJ2026-01-30
06438394005266Activa InstrumentBioretec OyHTJ2026-01-28
00840124525191DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525207DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00840124525214DynaBridgeFUSION ORTHOPEDICS, LLCHTJ2026-01-19
00841731135520Redemption VILEX LLCHTJ2026-01-13
00841506137520ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138077ProteanSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506138947Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
00841506145945Proximal Humerus Plating SystemSKELETAL DYNAMICS L.L.C.HTJ2025-12-01
04262494462580N/ADoppkon GmbH & Co. KGHTJ2025-12-01
08056693027987INTRAUMA SURGICAL INSTRUMENTINTRAUMA SPAHTJ2025-11-27
08800068959690LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25
08800068959706LOSPA Surgical InstrumentsCorentec Co., LtdHTJ2025-11-25