AccessGUDID - DEVICE: Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unit (EMAHKM715130)

GUDID

Device Identifier (DI) Information

Brand Name: Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unit
Version or Model: KM71-513
Commercial Distribution Status: In Commercial Distribution
Catalog Number: KM71-513
Company Name: mahe medical gmbh

Primary DI Number: EMAHKM715130
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: Steinmann pin w. trocar/round end 2.4mm/229mm, 6 pcs./unit

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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":	Yes
For Single-Use:	Yes
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?
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a K-Wire, it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	PIN, FIXATION, SMOOTH

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 28 Degrees Celsius
Handling Environment Humidity: between 10 and 50 Percent (%) Relative Humidity
Special Storage Condition, Specify: Cool, dark & dry place

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 2.4 Millimeter
Length: 229 Millimeter

Device Record Status

Public Device Record Key: 1e93e95c-86f8-440c-bdcf-7ad4b9d88a8f
Public Version Date: September 18, 2023
Public Version Number: 3
DI Record Publish Date: April 28, 2016