FDA.reportPublic FDA data

NA

Primary DI
10886982071927
Brand
NA
Company
Synthes GmbH
Model
03.110.021
Catalog number
03110021
Device description
1.8MM DRILL GUIDE WITH MEASURING FOR GUIDE BLOCK
Published
2016-12-31
Public version status
Update
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
07611819325081Direct MarkingGS10
10886982071927PrimaryGS10
H679031100210SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819325081076118193250817611819325081
1088698207192710886982071927

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
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
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
08800089415328INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089417230INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418350INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
08800089418374INLET System Surgical InstrumentJeil Medical CorporationHTJ2021-11-18
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
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
08806390859219VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28
08806390860031VERUM System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28