FDA.reportPublic FDA data

STRAIGHT DEPTH GAUGE

Primary DI
08057968719217
Brand
STRAIGHT DEPTH GAUGE
Company
HPF SRL
Model
9087.10.010
Published
2022-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
08057968719217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057968719217080579687192178057968719217

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
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
true
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
08057968716544STANDARD HANDLE M8 BLACKH50000600092022-09-09
08057968716551STANDARD HANDLE M8 BLUEH50000600192022-09-09
08057968716568STANDARD HANDLE M6 BLACKH50000600992022-09-09
08057968716575STANDARD HANDLE M6 BLUEH50000601092022-09-09
08057968716582STANDARD HANDLE CANNULATED M6 BLACKH50000601692022-09-09
08057968716599STANDARD HANDLE CANNULATED M6 BLUEH50000601792022-09-09
08057968716605STANDARD RATCHET HANDLE BLACKH50000600392022-09-09
08057968716612STANDARD RATCHET HANDLE BLUEH50000600492022-09-09
08055727370785FLEX. CARDANIC SCREWDRIVER COATED HEX. 3,5 mm CONN. ZIMMER01.32.10.02902022-09-08
08055727374479MIS 3.3 REAMER HANDLEH00325110992022-09-08
08055727374486MIS 3.3 REAMER HANDLEH00325120992022-09-08
08055727374493MIS 3.3 REAMER HANDLEH00325130992022-09-08
08055727374509MIS 3.3 REAMER HANDLEH00325140992022-09-08
08055727374516MIS 3.3 REAMER HANDLEH00325200992022-09-08
08055727374523MIS 3.3 REAMER HANDLEH00325210992022-09-08
08055727374530MIS 3.3 REAMER HANDLEH00325220992022-09-08
08055727374547MIS 3.3 REAMER HANDLEH00325230992022-09-08
08055727374554MIS 3.3 REAMER HANDLEH00325240992022-09-08
08057968711525ADAPTER HC/HPFH00305000092022-09-08
08057968716407LIGHTENED TRIAL HEAD D42 mmH00500515062022-09-08

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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
00815432028412MotoBAND CP Non Locking Drill GuideCROSSROADS EXTREMITY SYSTEMSHTJ2022-11-30
B56251300SDG000G10WishBone Plate & Screw SystemWishbone Medical, Inc.HTJ2022-07-18