AccessGUDID - DEVICE: Distal radius plate 7/3 holes,left, polyaxial (EMAH1506600205S0)

GUDID

Device Identifier (DI) Information

Brand Name: Distal radius plate 7/3 holes,left, polyaxial
Version or Model: 150-6600-205-S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 150-6600-205-S
Company Name: mahe medical gmbh

Primary DI Number: EMAH1506600205S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: Distal radius plate 7/3 holes,left, polyaxial

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":	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?
61688	Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, sterile	A sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HRS	Plate, fixation, bone

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: Yes
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
Storage Environment Humidity: between 10 and 50 Percent (%) Relative Humidity
Special Storage Condition, Specify: cool,dry,dark place

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 7/3 holes, plate, polyaxial
Length: 53.3 Millimeter

Device Record Status

Public Device Record Key: cefa853b-e88c-476d-9c9c-15070094993c
Public Version Date: February 19, 2024
Public Version Number: 3
DI Record Publish Date: August 02, 2016