MECRON Belt B: 29 cm, U: 130-157 cm 38-7450

GUDID 10609271950174

XL White 4-tape bandage

DARCO INTERNATIONAL, INC.

Abdominal binder, reusable
Primary Device ID10609271950174
NIH Device Record Keyda52b0b9-46f2-4c75-8a42-9742206e84d8
Commercial Distribution StatusIn Commercial Distribution
Brand NameMECRON Belt B: 29 cm, U: 130-157 cm
Version Model Number38-7450
Catalog Number38-7450
Company DUNS184231298
Company NameDARCO INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100609271950177 [Primary]
GS110609271950174 [Package]
Contains: 00609271950177
Package: Box [12 Units]
In Commercial Distribution

FDA Product Code

IPXORTHOSIS, RIB FRACTURE, SOFT

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-22
Device Publish Date2023-02-14

Devices Manufactured by DARCO INTERNATIONAL, INC.

20609271040025 - Body Armor® Stirrup Walker2023-11-10 Tall, white (medium)
10609271040035 - Body Armor® Stirrup Walker2023-11-10 Tall, white (large)
20609271040049 - Body Armor® Stirrup Walker2023-11-10 Tall, white (x-large)
10609271040226 - Body Armor® Stirrup Walker2023-11-10 Tall, gray (medium)
10609271040233 - Body Armor® Stirrup Walker2023-11-10 Tall, gray (large)
20609271040247 - Body Armor® Stirrup Walker2023-11-10 Tall, gray (x-large)
10609271040004 - Body Armor® Stirrup Walker2023-10-02 Tall, white (x-small)
20609271040018 - Body Armor® Stirrup Walker2023-10-02 Tall, white (small)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.