FDA.reportPublic FDA data

Depth Gauge Accessory Pack

Primary DI
00857676008782
Brand
Depth Gauge Accessory Pack
Company
Eca Medical Instruments
Model
1006
Published
2025-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857676008782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857676008782008576760087828576760087820857676008782

GMDN Terms#

Term, Definition table
TermDefinition
Surgical depth gauge, single-useA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone to determine the length of the bone screw to be used. It may take the form of: 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; or 3) a cylindrical rod with markings. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
084330422
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)228-TXRX-006228-TXRX-0062026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)228-TXRX-007228-TXRX-0072026-06-05
00857676008911IM NAIL PERCUTANEOUS DEPTH GAUGE STERILE (1043)104310432026-04-02
00850078396105IM NAIL DISPOSABLE HANDLE STERILE (1044)104410442026-03-10
00857676008812IM NAIL FRACTURE REDUCTION GUIDE STERILE (1012)10122025-06-17
00857676008874TruTORQ Medium Axial Handle, Sterile, Single Use, With T8101010102026-02-25
00850078396082TruPWR Torque Limiting Attachment Sterile, Single Use 11.3Nm228-TXRX-005228-TXRX-0052026-02-04
00850078396129TransLoc 3D, Depth Gauge for All-Metal Introducer103010302026-01-21
00850078396136iFuse INTRA Ti Instrument Kit102910292026-01-12
00850078396143Invictus Power FT, 110in-lb/12.4Nm228-TXRX-004228-TXRX-0042026-01-05
00850078396075Arsenal Foot™ Bone Harvesting Kit, Ø 8.0mm104010402025-12-18
00850078396280TRAQ Single Use Instrument Kit104210422025-12-12
008576760089284.0, 3.5, 2.5 - ACUTRAK 3 MIS BUNION INSTRUMENT KIT (1028-001)1028-0011028-0012025-11-11
008576760089353.6/4.5mm - INnate Instrument Kit (1028-002)1028-0021028-0022025-11-11
00857676008942 2.0 - ACUTRAK 3 NANO INSTRUMENT KIT (1027-001)1027-0011027-0012025-11-11
008576760089592.5 - ACUTRAK 3 MICRO INSTRUMENT KIT (1027-002)1027-0021027-0022025-11-11
008576760089663.5 - ACUTRAK 3 MINI INSTRUMENT KIT (1027-003)1027-0031027-0032025-11-11
008576760089734.0 - ACUTRAK 3 STANDARD INSTRUMENT KIT (1027-004)1027-0041027-0042025-11-11
008576760089803.6 mm - INNATE INSTRUMENT KIT(1027-005)1027-0051027-0052025-11-11
008576760089974.5 mm - INNATE INSTRUMENT KIT (1027-006)1027-0061027-0062025-11-11

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