FDA.reportPublic FDA data

HammerFiX

Primary DI
00842078100219
Brand
HammerFiX
Company
EXTREMITY MEDICAL, LLC
Model
132-00111
Device description
Cleaning Brush - 1.1mm
Published
2026-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00842078100219PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842078100219008420781002198420781002190842078100219

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/endoscope cleaning utensil, single-useA non-absorbent, non-powered, hand-held device in the form of a brush, a wire, strip of metal, or handle intended to clean the exterior and/or interior (lumen) of a surgical instrument (e.g., bur, reamer, bone tap, suturing device, sheath/shaft, ultrasonic surgical handpiece) and/or endoscope. The bristles, fibres or spines of brushes may be mounted along a single plane or radiate out around a central shaft, and may be soft or stiff; the shaft/handle of brushes may be flexible or rigid. The device may be used to clean endoscopic or open-surgery instruments, and it may have a handle or a connector/adaptor at the proximal end. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
832720358
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
00842078100004HammerFiX132-00050-S2026-10-29
00842078100011HammerFiX132-02800-S2026-10-29
00842078100028HammerFiX132-03400-S2026-10-29
00842078100035HammerFiX132-04000-S2026-10-29
00842078100127HammerFiX132-000112026-10-29
00842078100134HammerFiX132-000142026-10-29
00842078100141HammerFiX132-000162026-10-29
00842078100295IO FiX101-000042026-10-29
00842078100318XMCP101-000062026-10-29
00842078100363IO FiX101-000112026-10-29
00842078100370IO FiX101-000122026-10-29
00842078100387IO FiX101-000132026-10-29
00842078100479IO FiX101-000222026-10-29
00842078100486XMCP101-000232026-10-29
00842078101773XMCP102-000022026-10-29
00842078101889Jones Union102-000332026-10-29
00842078102794IO FiX118-000042026-10-29
00842078102800IO FiX118-000052026-10-29
00842078102817IO FiX118-000062026-10-29
00842078103197IO FiX 2.0118-020302026-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606197472OMEGA XPSPINAL ELEMENTS, INC.LXH2026-10-29
00842078100479IO FiXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078100486XMCPEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078112410Axis BeamsEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078116197AlignXEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124185Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129609KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129777IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129784IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129791IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
04250337122432iLESSYS® Interlaminar Endoscopic Surgical SystemJoimax GmbHLXH2026-10-29
07630699700689Knee InstrumentsMedacta International SALXH2026-10-29
08800017276182LOSPACorentec Co., LtdLXH2026-10-29
08806373878039LOSPACorentec Co., LtdLXH2026-10-29
08806373889653LOSPACorentec Co., LtdLXH2026-10-29
08806373894190LOSPACorentec Co., LtdLXH2026-10-29
10850070500101Core Wire, Removal Tool, ReusableCURVAFIX, INC.LXH2026-10-29
10855068008935Removal Tool Core Wire, DisposableCURVAFIX, INC.LXH2026-10-29
10888857615779K2M General InstrumentsVB Spine LLCLXH2026-10-28
M739193990906Non-Modular Convex TrialCAPTIVA SPINE, INC.LXH2026-10-28
M739193996906Non-Modular Lordotic Trial AssemblyCAPTIVA SPINE, INC.LXH2026-10-28
M739243999005SG Implant Driver-SCAPTIVA SPINE, INC.LXH2026-10-28
M739985202229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28
M739985203229Marking PinCAPTIVA SPINE, INC.LXH2026-10-28