FDA.report

PT,TAPING STATION,5 UPH TOPS,36hx216x42d

Primary DI
00840314810465
Brand
PT,TAPING STATION,5 UPH TOPS,36hx216x42d
Company
Hausmann Enterprises, LLC
Model
A9551
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
KMNChair And Table, Medical

Product Code Classifications

CodeDeviceSpecialtyClass
KMNChair And Table, MedicalGeneral Hospital1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840314810465PrimaryGS10

GMDN Terms

TermDefinition
Examination/treatment table, manualA non-mobile table designed for routine/minor medical examinations and/or treatment of the patient. It will typically consist of a framework with a flat table top surface which may have a head section that can be manually adjusted into a raised position. The height of the table may also be manually adjusted to fixed positions (i.e., set to an initial height but not readily adjustable). It may facilitate a paper roll holder from which paper is pulled to cover the table surface as a hygienic barrier for each new patient. This device is typically used in examination rooms or doctors' surgeries as a statically placed table.

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
true
Serial number
false
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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