AccessGUDID - DEVICE: Humeral IM reamer Ø8.5 x 345 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall coup. (07640187915723)

GUDID

Device Identifier (DI) Information

Brand Name: Humeral IM reamer Ø8.5 x 345 mm, can. Ø2.3 mm, Stryker/Zimmer-Hall coup.
Version or Model: T7646
Commercial Distribution Status: In Commercial Distribution
Catalog Number: T7646
Company Name: MPS Micro Precision Systems AG

Primary DI Number: 07640187915723
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 482204059 *Terms of Use

Device Description: Humeral monobloc intramedullary reamer is used to ream the medullary cavity of humeral bone prior to placing a nail. A range of diameter is proposed in regards with the nail to be implanted and a range of length is proposed in regards with the height of the bone. Different distal coupling are available to connect with existing power tool. This is a reusable device.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35297	Medullary canal orthopaedic reamer, flexible	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTO	Reamer

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9c05017b-42b9-4886-a6c1-4bd864172cc1
Public Version Date: November 18, 2022
Public Version Number: 2
DI Record Publish Date: August 14, 2020