FDA.reportPublic FDA data

Reliance

Primary DI
00850020301331
Brand
Reliance
Company
HAAG-STREIT USA, INC.
Model
510 ENT Cabinet
Published
2020-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ETFUnit, Examining/Treatment, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ETFUnit, Examining/Treatment, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020301331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020301331008500203013318500203013310850020301331

GMDN Terms#

Term, Definition table
TermDefinition
ENT examination/treatment systemAn assembly of devices intended to support a patient in a supine or reclining position and provide specialized features for an ear/nose/throat (ENT) examination or treatment. It typically includes a table and/or chair and functional components such as a suction/blowing apparatus, equipment drawers, and a mirror heater.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080962286
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850020301638RelianceElara Tabletop2026-05-29
00850020301607Reliance7800/ 7900 Refractor Arm-WC2025-08-04
00850020301614Reliance7800/ 7900 Refractor Arm-WC Value2025-08-04
00850020301621Reliance7800/ 7900 Third Arm2025-08-04
00850020301584Reliance7900V Floor Unit2025-05-21
00850020301539Reliance7900 Floor Unit2025-04-24
00850020301546RelianceBI Imaging2025-04-24
00850020301553RelianceBI-BM Rheostat2025-04-24
00850020301560RelianceBP-BQ Imaging2025-04-24
00850020301577RelianceBP-BQ Rheostat2025-04-24
00850020301591Reliance522V Chair2025-03-28
00850020301522Haag-Streit Surgical900 Surgical Chair2024-01-03
00850020301188RelianceEclipse2020-09-09
00850020301195Reliance7800/ 7900 Refractor Arm2020-09-09
00850020301201RelianceMonitor Arm2020-09-09
00850020301218RelianceWall Unit2020-09-09
00850020301225Reliance7900 Floor Unit2020-09-09
00850020301003RelianceFX520 Chair2020-09-09
00850020301010Reliance7000 Chair2020-09-09
00850020301027Reliance710 Chair2020-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840183530549BR Surgical, LLCBR Surgical, LLCETF2025-09-05
00840183529918BR Surgical, LLCBR Surgical, LLCETF2025-07-16
04250365149791ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149807ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149814ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149821ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149838ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365149845ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164084ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164107ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365164114ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365166187ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174960ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174977ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365174984ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365175417ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365175677ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190762ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190809ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
04250365190816ATMOSATMOS MedizinTechnik GmbH & Co. KGETF2024-11-27
00840183528447BR Surgical, LLCBR Surgical, LLCETF2024-11-07
00840183528461BR Surgical, LLCBR Surgical, LLCETF2024-11-07
00840183528300BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528478BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528485BR Surgical, LLCBR Surgical, LLCETF2024-11-06
00840183528386BR Surgical, LLCBR Surgical, LLCETF2024-10-29
00840183528492BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183528508BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183528515BR Surgical, LLCBR Surgical, LLCETF2024-10-28
00840183502997BR Surgical, LLCBR Surgical, LLCETF2024-07-23