Duns Number:073814568
Device Description: Flexible Infant - Pediatric Stirrups are firm, yet gentle. Used with small infants approxi Flexible Infant - Pediatric Stirrups are firm, yet gentle. Used with small infants approximately two years in age. Assists in placing the patient in lithotomy position when access to the perineum is required. Flexible construction allows for infinite adjustment of position. Over-extension is easily avoided, even after draping. Disposable loop style straps help avoid cross contamination from patient to patient. Built-in rail clamps provide quick set-up. Disposable loop style straps are sold separately (BD010-S). Sold as a Pair.
Catalog Number
BD010
Brand Name
NA
Version/Model Number
BD010
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"
-
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
CCX
Product Code Name
Support, Patient Position
Public Device Record Key
1922f67a-c08f-422a-9cb0-69f04ac76181
Public Version Date
July 15, 2022
Public Version Number
1
DI Record Publish Date
July 07, 2022
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 | 264 |