FDA.reportPublic FDA data

Sleeve Office3

Primary DI
04260652350083
Brand
Sleeve Office3
Company
Romedis GmbH
Model
SA900
Catalog number
SA90030
Published
2020-05-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ISSProsthesis, Thigh Socket, External Component

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISSProsthesis, Thigh Socket, External ComponentPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260652350083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260652350083042606523500834260652350083

GMDN Terms#

Term, Definition table
TermDefinition
Prosthesis suspension systemA group of devices used to hold/fasten a prosthesis to the body. The devices include locking pins, belts, silicone or neoprene sleeves, wedges, clamps, and suction sockets.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341502320
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260652350069Sleeve Office1SA900SA900102020-05-25
04260652350076Sleeve Office2SA900SA900202020-05-25
04260652350090Sleeve Office4SA900SA900402020-05-25
04260652350106Sleeve heavy-duty1SA900SA9001H2020-05-25
04260652350113Sleeve heavy-duty2SA900SA9002H2020-05-25
04260652350120Sleeve heavy-duty3SA900SA9003H2020-05-25
04260652350137Sleeve heavy-duty4SA900SA9004H2020-05-25
04260652350014Aqua Liner XSSA701.1XSSA701.1XS2019-10-11
04260652350021Aqua Liner SSA701.2SSA701.2S2019-10-11
04260652350038Aqua Liner MSA701.3MSA701.3M2019-10-11
04260652350045Aqua Liner LSA701.4LSA701.4L2019-10-11
04260652350052Aqua Liner XLSA701.5XLSA701.5XL2019-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262429650532Lumo Socket A-1macu4 GmbHISS2026-07-18
04262429650549Lumo Socket A-2macu4 GmbHISS2026-07-18
04262429650556Lumo Socket A-3macu4 GmbHISS2026-07-18
04262429650624Lumo Socket A-4macu4 GmbHISS2026-07-18
04262429650631Lumo Socket B-1macu4 GmbHISS2026-07-18
04262429650891Lumo Socket B-2macu4 GmbHISS2026-07-18
04262429650907Lumo Socket B-3macu4 GmbHISS2026-07-18
04262429650914Lumo Socket B-4macu4 GmbHISS2026-07-18
04262429650921Lumo Socket C-1macu4 GmbHISS2026-07-18
04262429650938Lumo Socket C-2macu4 GmbHISS2026-07-18
04262429650945Lumo Socket C-3macu4 GmbHISS2026-07-18
04262429650952Lumo Socket C-4macu4 GmbHISS2026-07-18
04262429650969Lumo Socket D-1macu4 GmbHISS2026-07-18
04262429650976Lumo Socket D-2macu4 GmbHISS2026-07-18
04262429650983Lumo Socket D-3macu4 GmbHISS2026-07-18
04262429650990Lumo Socket D-4macu4 GmbHISS2026-07-18
04262429651003Lumo Socket E-1macu4 GmbHISS2026-07-18
04262429651010Lumo Socket E-2macu4 GmbHISS2026-07-18
04262429651027Lumo Socket E-3macu4 GmbHISS2026-07-18
04262429651034Lumo Socket F-1macu4 GmbHISS2026-07-18
04262429651041Lumo Socket F-2macu4 GmbHISS2026-07-18
04262429651058Lumo Socket F-3macu4 GmbHISS2026-07-18
04262429651065Lumo Socket F-4macu4 GmbHISS2026-07-18
04262429651072Lumo Socket E-4macu4 GmbHISS2026-07-18
04262429650563Lumo Spacer, STD-Amacu4 GmbHISS2025-11-23
04262429650648Lumo Module Connectormacu4 GmbHISS2025-11-23
04262429650655Lumo Spacer, STD-Bmacu4 GmbHISS2025-11-23
04262429650662Lumo Spacer, STD-Cmacu4 GmbHISS2025-11-23
04262429650679Lumo Spacer, STD-Dmacu4 GmbHISS2025-11-23
04262429650686Lumo Spacer, STD-Emacu4 GmbHISS2025-11-23