LB56

GUDID 00724995153182

The STERIS Harmony rSheild is a radiation proton device with 23.6-inch tube mounts to the STERIS Lighting Visualization Systems.

STERIS CORPORATION

Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed Radiation shielding panel, fixed
Primary Device ID00724995153182
NIH Device Record Key59283234-d052-4a7b-a1fa-7a5b3e91ae68
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberrShield
Catalog NumberLB56
Company DUNS036985604
Company NameSTERIS CORPORATION
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 Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx
Phone+1(800)548-4873
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS100724995153182 [Primary]

FDA Product Code

KPYShield, protective, personnel

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-04-08
Device Publish Date2021-03-31

Devices Manufactured by STERIS CORPORATION

00724995152970 - NA2021-04-12 The Plastic LightHandle non-sterile is for receiving disposable light handle cover and used with HarmonyAIR and Harmony Surgical
00724995152987 - NA2021-04-12 The Aluminum Sterilizable Handle is a reusable surgical light handle without sterile surgeon control.
00724995152994 - NA2021-04-12 The Surgeon Control Sterilizable Handle provides sterile surgeon control of surgical light intensity, pattern, power and positio
00724995153007 - NA2021-04-12 The Silicone Ring is used with the Sterilizable Aluminum Light Handle.
00724995156428 - NA2021-04-12 The 2-inch TLT Pad - Head Section is used with surgical tables.
00724995156435 - NA2021-04-12 The 2-inch TLT Pad for Back Section is used with surgical tables.
00724995156442 - NA2021-04-12 The 2-inch TLT Table Pads Complete Set is used with the STERIS Cmax, 4085 and 5085 General Surgical Table.
00724995156459 - NA2021-04-12 The 5085 Harmony Standard Headrest with 2-inch PRS Pads is used with the 5085 Harmony Surgical Table.

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