Duns Number:790605856
Device Description: Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Roll must b Latex-Free Reusable abdominal belt with button holes. Gray, elastic, washable. Roll must be cut to length. Water-resistant. 1 roll. Length = 50' (15m)Width = 1 1/4" (32mm)
Catalog Number
M4601A
Brand Name
Fetal Measurements
Version/Model Number
REUSABLE LEG BELT- 32MM X 15M
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
HGM
Product Code Name
SYSTEM, MONITORING, PERINATAL
Public Device Record Key
e4eea8e5-70b4-4638-9a0e-01e304ee78d5
Public Version Date
March 03, 2022
Public Version Number
8
DI Record Publish Date
October 03, 2016
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 | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 323 |
| 3 | A medical device with high risk that requires premarket approval | 36 |
| U | Unclassified | 1 |