FDA.reportPublic FDA data

Fixed Head Reamer, Ø10mm

Primary DI
09120116978121
Brand
Fixed Head Reamer, Ø10mm
Company
I.T.S. GmbH
Model
1UI224A
Catalog number
1UI224A
Device description
Fixed Head Reamer, Ø10mm
Published
2024-08-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120116978121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120116978121091201169781219120116978121

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep out of sunlight

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
303456917
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
09120047301241Cannulated Tibia Nail11210-36011210-3602016-09-14
09120047301364Cannulated Tibia Nail11209-28511209-2852016-09-14
09120047301371Cannulated Tibia Nail11209-30011209-3002016-09-14
09120047301388Cannulated Tibia Nail11209-40511209-4052016-09-14
09120047301395Cannulated Tibia Nail11210-28511210-2852016-09-14
09120047301418Cannulated Tibia Nail11209-33011209-3302016-09-14
09120047301425Cannulated Tibia Nail11209-34511209-3452016-09-14
09120047301432Cannulated Tibia Nail11209-36011209-3602016-09-14
09120047301449Cannulated Tibia Nail11209-37511209-3752016-09-14
09120047301456Cannulated Tibia Nail11209-39011209-3902016-09-14
09120047301692Cannulated Tibia Nail11210-31511210-3152016-09-14
09120047301722Cannulated Tibia Nail11210-33011210-3302016-09-14
09120047301739Cannulated Tibia Nail11210-34511210-3452016-09-14
09120047301968Cannulated Tibia Nail11209-31511209-3152016-09-14
09120047302118Cannulated Tibia Nail11210-39011210-3902016-09-14
09120047302156Cannulated Femur Nail, Right12110-30012110-3002016-09-14
09120047302163Cannulated Femur Nail, Left12210-30012210-3002016-09-14
09120047302194Cannulated Femur Nail, Right12112-30012112-3002016-09-14
09120047302200Cannulated Femur Nail, Left12212-30012212-3002016-09-14
09120047303214Cannulated Femur Nail, Right12112-42012112-4202016-09-14

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Primary DI, Brand, Company table
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00888867531628Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531635Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531680Arthrex®ARTHREX, INC.HWE2026-03-16
00888867531727Arthrex®ARTHREX, INC.HWE2026-03-16
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09421038412169Offset drive train, lockingENZTEC LIMITEDHWE2026-03-09
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09421038412183Handle – UnitedENZTEC LIMITEDHWE2026-03-09
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09421038412305Offset coupling, AOENZTEC LIMITEDHWE2026-03-09
09421038412312Cup reamer handle, offset, AO, openENZTEC LIMITEDHWE2026-03-09
09421038412329Offset drive train, openENZTEC LIMITEDHWE2026-03-09
09421038412671Cup reamer handle, offset, Z/H, openENZTEC LIMITEDHWE2026-03-09
00810111225601ReamerTreace Medical Concepts, Inc.HWE2026-03-02
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