FDA.report

ACUMED

Primary DI
10806378045554
Brand
ACUMED
Company
Acumed LLC
Model
80-0946
Device description
Acutrak 2® - 4.7 Long Drill
Published
2015-10-24
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
true

Related Records

Contact Domains

Product Codes

CodeName
HTWBIT, DRILL

Product Code Classifications

CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10806378045554PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1080637804555410806378045554

GMDN Terms

TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(888)627-9957businessservices@acumed.net

Regulatory Flags

DUNS number
196884852
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

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10806378124310ACUMED7006-3401N2025-12-08
10806378124327ACUMED7006-3402L2025-12-08
10806378124334ACUMED7006-3402R2025-12-08
10806378124341ACUMED7006-3403L2025-12-08
10806378124358ACUMED7006-3403R2025-12-08
10806378124365ACUMED3073-000002025-12-08
10806378124372ACUMED7006-3301N2025-12-08
10806378124389ACUMED7006-3302N2025-12-08
10806378124662ACUMED7006-3201L2025-12-08
10806378124679ACUMED7006-3201R2025-12-08
10806378124686ACUMED7006-3202L2025-12-08

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06974940307038endophixSuzhou Endophix Co., Ltd.HTW2026-03-03
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