FDA.reportPublic FDA data

NA

Primary DI
07611819348622
Brand
NA
Company
Synthes GmbH
Model
03.113.014
Catalog number
03113014
Device description
HANDLE F/PERCUTANEOUS THREADED DRILL GUIDES
Published
2016-12-31
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
07611819348622Direct MarkingGS10
10886982072818PrimaryGS10
H679031130140SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819348622076118193486227611819348622
1088698207281810886982072818

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809513720045SAEHAN Hydraulic Pinch GaugeSaehan CorporationHTJ2026-05-18
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
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
08806390862592Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHTJ2018-11-28