Model: WSLIDEBARHNDLRED
DI: 06972077026709
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
dbea5400-7643-490e-9350-a6e5b5aef506
Distribution Status:
In Commercial Distribution
DUNS Number:
530563253
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06972077026709
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 45127
Name: Infant whole-body restraint, reusable
Definition:
A device intended to be used to temporarily render an infant's whole body immovable (strait-jacket effect) while the patient undergoes therapeutic or diagnostic interventions. It includes non-rigid fabric and/or plastic components but might also include a rigid structural component (e.g., board). This is a reusable device.
FDA Product Codes
KNN
Components, Wheelchair