FDA.reportPublic FDA data

Rigid UAS left

Primary DI
08719425709321
Brand
Rigid UAS left
Company
MACROMEDICS B.V.
Model
UTB-RASL
Catalog number
125300L
Device description
UTB rigid upper armsupport, left
Published
2023-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719425709321PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719425709321087194257093218719425709321

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
489730120
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08720168162595Mask DSPS®-PROSH set/51139102026-04-23
08720168162564DSPS-Prominent® Cradle-II1131502026-04-22
08720168162571Mask DSPS®-PROSHVRL set/51138902026-04-22
08720168162618Mask DSPS®-PROSHL set/51139202026-04-22
08720168162649Mask DSPS®-PROSHVR set/51139402026-04-22
08720168162748Mask DSPS®-PROH, set/51139302026-04-22
08720168162755Mask DSPS®-PRO, set/51139902026-04-22
08720168162779DSPS-Prominent® Cradle-III1131602026-04-22
08720168162786DSPS-Prominent® Cradle-IV1131702026-04-22
08720168162793DSPS-Prominent® Cradle-VI1131802026-04-22
08720168162854Mask DSPS®-PROSCVRL set/51137602026-04-22
08720168162861Mask DSPS®-PROSC set/51137702026-04-22
08720168162878Mask DSPS®-PROSCVR set/51137802026-04-22
08720168162885Mask DSPS®-PROSCL set/51137902026-04-22
08720168163325DSPS-Prominent® Cradle-VII1132602026-04-22
08720168163356DSPS-Prominent® SH profile set/21130902026-04-22
08720168163387DSPS PRO Mask Shim Set HNS1132502026-04-22
08720168163394DSPS PRO Mask Shim Set HO1132702026-04-22
08720168160140DSPS-Prominent® baseplate 1131202026-04-21
08720168162557DSPS-Prominent® Cradle-I1131402026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817355027046KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00840510401696KLARITY MEDICALKlarity Medical Products, LLCIYE2026-11-04
00841439120590TotalRTQfixIYE2026-11-04
00817355025400KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-28
00850065937403eMotusEMPNIA INC.IYE2026-10-27
00850065937410eMotusEMPNIA INC.IYE2026-10-27
00817355025127KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-26
00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21