FDA.report

UNO

Primary DI
06430053264243
Brand
UNO
Company
Dassiet Oy
Model
U-EMS3
Device description
Emergency splint
Published
2022-09-30
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
true

Related Records

Contact Domains

Product Codes

CodeName
NOCSplint, Extremity, Non-Inflatable, External, Non-Sterile

Product Code Classifications

CodeDeviceSpecialtyClass
NOCSplint, Extremity, Non-Inflatable, External, Non-SterileGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
06430053264243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
06430053264243064300532642436430053264243

GMDN Terms

TermDefinition
First aid limb splint, mouldable, single-useA portable device intended to be used for emergency immobilization of an injured body extremity (arm or leg). It takes the form of a semi-rigid, padded, metallic sheet, or a wire frame, or a thermoplastic material designed to be manually moulded/curved externally around the limb to create a rigid splint. It is typically intended to be used by emergency medical services (EMS). This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+358504664642info@dassiet.com

Regulatory Flags

DUNS number
651254398
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
true
Expiration date on label
true
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 DIBrandModelCatalogPublished
06430053260238WOODCASTC1465 Black2024-08-11
06430053260252WOODCASTB1565 Black2024-08-11
06430053265837WOODCASTB1580 Black2024-08-11
06430053269842PROCASTX04152024-08-05
06430053261549WOODCASTC1441 Black2024-03-21
06430053260207WOODCASTC14652022-09-30
06430053260214WOODCASTB15652022-09-30
06430053261389WOODCASTC1434 black2022-09-30
06430053261419WOODCASTC1434S2022-09-30
06430053261488WOODCASTC1434S Black2022-09-30
06430053261525WOODCASTC14412022-09-30
06430053264007UCASTU-WRIST2022-09-30
06430053264274UCASTU-THUMB-SH2022-09-30
06430053264328UCASTU-THUMB2022-09-30
06430053264335UCASTU-MC2022-09-30
06450053264296UCASTU-HUM-L2022-09-30
06450053264289UCASTU-HUM-R2022-09-30
06450053264302UCASTU-TOE2022-09-30
06430053263123UCASTU-FINGER-SM2022-09-30
06430053263130UCASTU-FINGER-ML2022-09-30

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190446683407PROCAREDJO, LLCNOC2025-07-08
00190446683414PROCAREDJO, LLCNOC2025-07-08
00190446662754PROCAREDJO, LLCNOC2025-07-07
00190446662761PROCAREDJO, LLCNOC2025-07-07
00190446662778PROCAREDJO, LLCNOC2025-07-07
14251853902826Body Armor® PFA WalkerDarco (Europe) GmbHNOC2025-04-15
14251853902833Body Armor® PFA WalkerDarco (Europe) GmbHNOC2025-04-15
14251853902840Body Armor® PFA WalkerDarco (Europe) GmbHNOC2025-04-15
08809818038111Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038128Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038135Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038142Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038159Guardian SplintBM KOREA CO., LTDNOC2025-03-20
08809818038166Guardian SplintBM KOREA CO., LTDNOC2025-03-20
06977071937501MeicenGuangdong Meicen Medical Equipment Co., Ltd.NOC2024-06-21
00810003753700KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753724KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753748KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753762KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753861KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753885KENAFLEXX KENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753908KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753922KENAFLEXXKENTRON HEALTHCARE, INC.NOC2024-02-19
00810003753540KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753564KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753588KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753601KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753625KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753649KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18
00810003753663KENTEXKENTRON HEALTHCARE, INC.NOC2024-02-18