FDA.reportPublic FDA data

BUG

Primary DI
08055715703571
Brand
BUG
Company
ORMESA SRL
Model
BUG MEDIUM 851 HIGH-LOW COMPACT BASE, DARK GREY PI
Device description
Postural sitting unit intended for children with disabilities (Infantile Cerebral Palsy, degenerative pathologies with functional impairments, syndromic pathologies with impairments functional) easily adaptable thanks to its modularity. Suitable for users who have little or no control of the trunk and head and needing appropriate stabilization a pelvic level to be able to assume, in situations where residual functionality allows it, the more appropriate posture in different everyday contexts, both internally and externally.
Published
2025-01-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
INMChair, With Casters

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
INMChair, With CastersPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08055715703571PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08055715703571080557157035718055715703571

GMDN Terms#

Term, Definition table
TermDefinition
Assistive pushchairA wheeled mobility device manually propelled by an attendant that consists of a open framework with one or more handle(s) designed to carry one or more person(s) with a disability in a seated or semi-lying (semi-recumbent) position.

Regulatory Flags#

DUNS number
432070019
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08054040400612ADJUSTABLE TROLLIADJUSTABLE TROLLI 36 NERO+951+8232026-09-06
08054040400629ADJUSTABLE TROLLIADJUSTABLE TROLLI 36 ROSSO+951+8232026-09-06
08054040400636ADJUSTABLE TROLLIADJUSTABLE TROLLI 40 ROSSO+951+8232026-09-06
08054040400643ADJUSTABLE TROLLIADJUSTABLE TROLLI 40 NERO +951+8232026-09-06
08054040400650ADJUSTABLE TROLLIADJUSTABLE TROLLI 43 NERO +951+8232026-09-06
08054040400667ADJUSTABLE TROLLIADJUSTABLE TROLLI 43 ROSSO+951+8232026-09-06
08054040402074ADJUSTABLE TROLLITROLLI REGOLABILE 36 NERO+823+9582026-09-06
08054040402081ADJUSTABLE TROLLITROLLI REGOLABILE 40 NERO+823+9582026-09-06
08054040402098ADJUSTABLE TROLLITROLLI REGOLABILE 43 NERO+823+9582026-09-06
08054040402104ADJUSTABLE TROLLITROLLI REGOLABILE-40 ROSSO 8632026-09-06
08054040402111ADJUSTABLE TROLLITROLLI REGOLABILE-36 ROSSO 8632026-09-06
08054040402128ADJUSTABLE TROLLITROLLI REGOLABILE-43 ROSSO 8632026-09-06
08054040402210ADJUSTABLE TROLLITROLLI REGOLABILE 36 ROSSO+823+9582026-09-06
08054040402227ADJUSTABLE TROLLITROLLI REGOLABILE-36 NERO 951,8632026-09-06
08054040402234ADJUSTABLE TROLLITROLLI REGOLABILE-36 ROSSO 951,8632026-09-06
08054040402241ADJUSTABLE TROLLITROLLI REGOLABILE-40 NERO 951,8632026-09-06
08054040402258ADJUSTABLE TROLLITROLLI REGOLABILE-40 ROSSO 951,8632026-09-06
08054040402265ADJUSTABLE TROLLITROLLI REGOLABILE-43 NERO 951,8632026-09-06
08054040402272ADJUSTABLE TROLLITROLLI REGOLABILE-43 ROSSO 951,8632026-09-06
08054040402289ADJUSTABLE TROLLITROLLI REGOLABILE 36 NERO+823+9582026-09-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054040400612ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400629ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400636ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400643ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400650ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040400667ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402074ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402081ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402098ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402104ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402111ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402128ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402210ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402227ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402234ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402241ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402258ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402265ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402272ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402289ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402296ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402302ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402319ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402326ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402333ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402340ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402357ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402364ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402371ADJUSTABLE TROLLIORMESA SRLINM2026-09-06
08054040402388ADJUSTABLE TROLLIORMESA SRLINM2026-09-06