Busse Hospital Disosables

GUDID 20849233004874

Shoe Covers

ROBERT BUSSE & CO., INC.

Shoe cover
Primary Device ID20849233004874
NIH Device Record Key9e88ecfb-8e09-4ff5-ac70-6057bc90601a
Commercial Distribution StatusIn Commercial Distribution
Brand NameBusse Hospital Disosables
Version Model Number340
Company DUNS002418234
Company NameROBERT BUSSE & CO., 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com
Phone631-435-4711
Emailmail@busseinc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS110849233004877 [Primary]
GS120849233004874 [Package]
Contains: 10849233004877
Package: [158 Units]
In Commercial Distribution

FDA Product Code

FPXStrip, Adhesive, Closure, Skin
FXPCover, Shoe, Operating-Room

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-26
Device Publish Date2023-06-16

Devices Manufactured by ROBERT BUSSE & CO., INC.

10849233012834 - Busse Hospital Disposables2025-03-28 4.5MM SS Diamond Trocar Kit
10849233012827 - Busse Hospital Disposables2025-03-20 Pain Tray
10849233012810 - Busse Hospital Disposables2025-03-19 3.5MM SS Diamond Trocar Kit
10849233012780 - Busse Hospital Disposables2025-03-12 SNRB Tray
10849233012803 - Busse Hospital Disposables2025-03-12 Midline Epidural Tray
10849233012797 - Busse Hospital Disposables2025-03-11 Facet Block Tray
10849233012773 - Busse Hospital Disposables2025-03-05 Hormone Pellet Insertion Kit without Trocar Medium Glove & CHG
10849233012766 - Busse Hospital Disposables2025-02-24 Hormone Pellet Insertion Kit without Trocar - Large Glove & CHG - Sterile

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.