AccessGUDID - DEVICE: OsteoProbe Measurement Kit (00860001719390)

GUDID

Device Identifier (DI) Information

Brand Name: OsteoProbe Measurement Kit
Version or Model: OPD-907
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OPD-907
Company Name: Active Life Scientific, Inc.

Primary DI Number: 00860001719390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 004386740 *Terms of Use

Device Description: OsteoProbe Measurement Kit containing 1 sterile tip, 1 sterile cover, and 1 reference material block

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:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
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?
65718	Bone microindentation resistance measurement system	An electrically-powered assembly of devices intended to assess cortical bone quality by measuring its resistance to microindentation for identification of bone deficiencies missed by imaging that may increase bone fragility and fracture risk. It consists of a handpiece with connections to an adaptor and computing device where data is analysed and displayed; it is used with a single-use, patient-contact handpiece tip (not included).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QGQ	Bone Indentation Device

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN210013	000

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 Atmospheric Pressure: between 71 and 101 KiloPascal
Storage Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Atmospheric Pressure: between 71 and 101 KiloPascal
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Handling Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6b05478c-9df6-4551-b6b2-344d0f28df79
Public Version Date: January 05, 2022
Public Version Number: 1
DI Record Publish Date: December 28, 2021