AccessGUDID - DEVICE: TI HBS self-drilling high compression screw,cannulated,16mm (EMAHHBS100316S0)

GUDID

Device Identifier (DI) Information

Brand Name: TI HBS self-drilling high compression screw,cannulated,16mm
Version or Model: HBS-1003-16S
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HBS-1003-16S
Company Name: mahe medical gmbh

Primary DI Number: EMAHHBS100316S0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342243334 *Terms of Use

Device Description: TI HBS self-drilling high compression screw,cannulated,16mm Ø3.2/2.5mm

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?
56642	Orthopaedic bone screw, non-bioabsorbable, non-sterile	A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
HWC	Screw, 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: 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
Special Storage Condition, Specify: cool, dry & dark place
Storage Environment Humidity: between 10 and 50 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
Length: 16.0 Millimeter

Device Record Status

Public Device Record Key: 513ee679-b765-42ca-9b91-684cfd7acf1e
Public Version Date: February 19, 2024
Public Version Number: 3
DI Record Publish Date: September 07, 2016