FDA.report

Humeral IM reamer Ø7.5 x 343 mm, can. Ø2.3 mm Hudson coup.

Primary DI
07640187917802
Brand
Humeral IM reamer Ø7.5 x 343 mm, can. Ø2.3 mm Hudson coup.
Company
MPS Micro Precision Systems AG
Model
T13672
Catalog number
T13672
Published
2024-11-04
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
false

Related Records

Contact Domains

Product Codes

CodeName
HTOReamer

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640187917802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640187917802076401879178027640187917802

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, flexibleAn 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 device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
999-999-9999customers@mpsag.com

Regulatory Flags

DUNS number
482204059
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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07640187918151IM reamer shaft dove tail 470 mm, Big AO coup.T18821T188212025-05-30
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07640187918274IM reamer head dove tail Ø12 x 25 mm, can. Ø3.4 mmT18833T188332025-05-30
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07640187918311IM reamer head dove tail Ø16 x 30 mm, can. Ø3.4 mmT18837T188372025-05-30
07640187918328IM reamer head dove tail Ø17 x 31 mm, can. Ø3.4 mmT18838T188382025-05-30
07640187918335IM reamer head dove tail Ø18 x 32 mm, can. Ø3.4 mmT18839T188392025-05-30
07640187918342IM reamer head dove tail Ø19 x 33 mm, can. Ø3.4 mmT18840T188402025-05-30
07640187918359IM reamer head dove tail Ø20 x 34 mm, can. Ø3.4 mmT18841T188412025-05-30
07640187918366IM reamer head dove tail Ø21 x 35 mm, can. Ø3.4 mmT18867T188672025-05-30
07640187918373IM reamer head dove tail Ø22 x 36 mm, can. Ø3.4 mmT18868T188682025-05-30
07640187918380IM reamer head dove tail Ø23 x 38 mm, can. Ø3.4 mmT18869T188692025-05-30

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