Duns Number:005080650
Device Description: The Small Bone Caliper accurately measures distance in cm. It features a fixed arm and a The Small Bone Caliper accurately measures distance in cm. It features a fixed arm and a measurement arm that slides along a scale. The scale indicates the distance between the two arms. Calipers are used to measure body characteristics such as abdominal diameter, wrist, elbow and knee widths, muscle mass, shoulder and chest width, etc. The measurements are accurate to 1mm.
Catalog Number
01294
Brand Name
Small Bone Caliper
Version/Model Number
01294
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
KTZ
Product Code Name
Caliper
Public Device Record Key
d226092a-40f1-4bcd-a35e-5f601be8bb7a
Public Version Date
September 08, 2021
Public Version Number
1
DI Record Publish Date
August 31, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 21 |