FDA.reportPublic FDA data

DEPTH GAUGE 9 mm

Primary DI
08055727374561
Brand
DEPTH GAUGE 9 mm
Company
HPF SRL
Model
H0010354099
Published
2022-12-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08055727374561PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055727374561080557273745618055727374561

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
895802853
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08057968716742MIS 4.0 REAMER HANDLE CUP IMPACTORH00340000992022-09-08
08055727375285DROP HANDLE M8 BLUEH15000002092022-09-05
08055727375322DROP HANDLE CANNULATED M8 VIOLETH15000202192022-09-05
08055727375339DROP HANDLE CANNULATED M8 NIGHT BLUEH15000502192022-09-05
08055727375346DROP HANDLE CANNULATED M8 BLUEH15000002192022-09-05
08055727375353DROP HANDLE CANNULATED M8 BLACKH15000102192022-09-05
08055727375360"T" RATCHED HANDLE YELLOWH15000404092022-09-05
08055727375377"T" RATCHED HANDLE WHITEH15000304092022-09-05
08055727375384"T" RATCHED HANDLE VIOLETH15000204092022-09-05
08055727375391"T" RATCHED HANDLE NIGHT BLUEH15000504092022-09-05
08055727375407"T" RATCHED HANDLE CANNULATED NIGHT BLUEH15000504592022-09-05
08055727375414"T" RATCHED HANDLE CANNULATED YELLOWH15000404592022-09-05
08055727375421"T" RATCHED HANDLE CANNULATED WHITEH15000304592022-09-05
08055727375438"T" RATCHED HANDLE CANNULATED VIOLETH15000204592022-09-05
08055727375445"T" RATCHED HANDLE CANNULATED BLUEH15000004592022-09-05
08055727375452"T" RATCHED HANDLE CANNULATED BLACKH15000104592022-09-05
08055727375469"T" RATCHED HANDLE BLUEH15000004092022-09-05
08055727375476"T" RATCHED HANDLE BLACKH15000104092022-09-05
08055727375483"T" HANDLE M8 YELLOWH15000401592022-09-05
08055727375490"T" HANDLE M8 WHITEH15000301592022-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719886915273U-Motion IIUNITED ORTHOPEDIC CORP.HTJ2026-10-15
10886982345455VOLTSynthes GmbHHTJ2026-09-25
00840606191609Overwatch PCFSPINAL ELEMENTS, INC.HTJ2026-07-31
03700569674250Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
03700569674274Newclip InstrumentsNEWCLIP TECHNICSHTJ2026-07-27
00842188130311Tools - ScrewsTrimed, INC.HTJ2026-07-22
06974940307243endophixSuzhou Endophix Co., Ltd.HTJ2026-06-23
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
08809513720359SAEHAN Mechanical Pinch GaugeSaehan CorporationHTJ2026-05-18
08800322750001AnyPlus®GS Medical Co., Ltd.HTJ2026-04-21
00810112597486TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2026-02-10
10850070500484Cannulated Depth Guage CURVAFIX, INC.HTJ2025-10-22
00810135963404ImpactNVision Biomedical Technologies, Inc.HTJ2025-09-24
05055662971057ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHTJ2025-08-15
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
00810112597936MOTOBAND InstrumentsCROSSROADS EXTREMITY SYSTEMSHTJ2024-07-31
00810112592542TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2024-02-23
00810112592702TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2024-02-23
00810112592719TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHTJ2024-02-23
10885862573483EPICExactech, Inc.HTJ2024-01-08
B56251300MDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2024-01-01
07708604560472SAMPEDROINDUSTRIAS MEDICAS SAMPEDRO S A SHTJ2023-01-18
08055727374578DEPTH GAUGE 9 mmHPF SRLHTJ2022-12-09
10603295550273INHANCEDEPUY (IRELAND)HTJ2022-12-09
10855068008607Implant Selection DeviceCURVAFIX, INC.HTJ2022-12-05
00815432028412MotoBAND CP Non Locking Drill GuideCROSSROADS EXTREMITY SYSTEMSHTJ2022-11-30
08057968719217STRAIGHT DEPTH GAUGEHPF SRLHTJ2022-09-09