FDA.report

EXAM TABLE,ADA,POWERMATIC,W/O OUTLET,LH

Primary DI
00840314804822
Brand
EXAM TABLE,ADA,POWERMATIC,W/O OUTLET,LH
Company
Hausmann Enterprises, LLC
Model
4465-LD
Published
2022-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
INQTable, Powered
LGXTable, Examination, Medical, Powered

Product Code Classifications

CodeDeviceSpecialtyClass
INQTable, PoweredPhysical Medicine1
LGXTable, Examination, Medical, PoweredGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314804822PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840314804822008403148048228403148048220840314804822

GMDN Terms

TermDefinition
Examination/treatment table, line-poweredA mobile, mains electricity (AC-powered) motorized table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework or a large pedestal with a flat table top surface which consists of some articulated sections that can be adjusted into a raised position. The height of the table top surface will also be power-adjusted. It is typically used in examination rooms, endoscopy facilities, electrophysiology (EP) laboratories, or outpatient departments for minor interventions.

Sterilization Methods

Method

Regulatory Flags

DUNS number
001892660
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00840314811202ELASTIC ELBOW SUPPORT SMHM01342025-01-01
00840314811219ELASTIC ELBOW SUPPORT MDHM01352025-01-01
00840314811226ELASTIC ELBOW SUPPORT MDHM01362025-01-01
00840314811233ELASTIC ELBOW SUPPORT XLHM01372025-01-01
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