FDA.report

R82

Primary DI
05707292787293
Brand
R82
Company
R82 A/S
Model
x:panda SIZE-3
Catalog number
8910133-02
Published
2022-10-12
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
INNCHAIR, ADJUSTABLE, MECHANICAL

Product Code Classifications

CodeDeviceSpecialtyClass
INNChair, Adjustable, MechanicalPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
05707292787293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
05707292787293057072927872935707292787293

GMDN Terms

TermDefinition
Assistive ergonomic chair, manually-adjustedA non-electrical device, that may include pneumatically-assisted features, intended to support and position a patient (disabled and/or discomforted) in a sitting posture while performing activities of daily living, including work-related activities. It is designed with manually-operated ergonomic adjustments (e.g., height and position adjustments) to provide improved personal body posture and/or to help prevent/reduce physical problems associated with poor mobility or sedentary lifestyle. It is not a wheelchair.

Sterilization Methods

Method

Regulatory Flags

DUNS number
308022169
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

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05715393022809R82Addax SIZE 19120010002026-01-20
05715393022816R82Addax SIZE 19120010012026-01-20
05715393022823R82Addax SIZE 29120020002026-01-20
05715393022830R82Addax SIZE 29120020012026-01-20
05715393012275R82Flamingo Curo SIZE-18820012025-09-01
05715393012282R82Flamingo Curo SIZE-28820022025-09-01
05715393012299R82Flamingo Curo SIZE-38820032025-09-01
05715393021949R82Crocodile, Size 1 AT86801AT2025-05-15
05715393021956R82Crocodile, Size 2 AT86802AT2025-05-15
05715393021963R82Crocodile, Size 3 AT86803AT2025-05-15
05715393021970R82Crocodile, Size 1 AT86801AT-ATS2025-05-15
05715393021987R82Crocodile, Size 2 AT86802AT-ATS2025-05-15
05715393022014R82Crocodile, Size 3 AT86803AT-ATS2025-05-15
05715393013982R82Meerkat SIZE-1870011-1RS2024-09-13
05715393013999R82Meerkat SIZE-1870011-2RS2024-09-13
05715393014002R82Meerkat SIZE-2870022-RS2024-09-13
05715393014019R82Meerkat SIZE-3870023-RS2024-09-13
05707292975003R82Chilla SIZE 18811111002024-08-14
05707292975027R82Chilla SIZE 18811111102024-08-14
05707292975041R82Chilla SIZE 18811111202024-08-14

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