FDA UDI In Commercial Distribution 🇺🇸 United States

IM reamer shaft dove tail 470 mm, Big AO coup.

DI: 07640187918151 · Model: T18821 · MPS Micro Precision Systems AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
IM reamer shaft dove tail 470 mm, Big AO coup.
Primary DI
07640187918151
Version / Model
T18821
Catalog Number
T18821
Company Name
MPS Micro Precision Systems AG
Labeler DUNS
482204059
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-05-30
Public Version
1
Public Version Date
2025-06-09
Public Version Status
New
Public Device Record Key
fde7383b-3506-4b6e-adb5-8ee035d1fafc

Device Description

Intramedullary reamer shaft is used in combination with the Intramedullary reamer head to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable.

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Moist Heat or Steam Sterilization

Product Codes

Code Name
LXH Orthopedic Manual Surgical Instrument

GMDN Terms

Code Name
35297 Medullary canal orthopaedic reamer, flexible

Identifiers

Type ID
Primary 07640187918151

Customer Contacts

Phone
999-999-9999