FDA.reportPublic FDA data

EBERLE

Primary DI
04050052026974
Brand
EBERLE
Company
Eberle GmbH & Co. KG
Model
710002
Catalog number
710002
Device description
Introducer
Published
2018-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LHXTrousers, anti-shock

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHXTrousers, Anti-ShockCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050052026974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050052026974040500520269744050052026974

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, reusableA powered, rotational, cutting device designed for use in an arthroscopic shaver system handpiece for soft and bone tissue resection during arthroscopic surgery on a joint, e.g., a knee, shoulder, or ankle. It is locked into a handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector. The inner and outer tubes are typically made of high-grade stainless steel; the hub and connector may be made of stainless steel or a polymer [e.g., polyphenylsulfone (PPSU)]. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315919220
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04050052015800Eberle Shaver Blades914103591410352018-04-05
04050052015817Eberle Shaver Blades914104291410422018-04-05
04050052015831EBERLE914106591410652018-04-27
04050052015848EBERLE914112591411252018-06-16
04050052015855EBERLE914113591411352018-06-16
04050052015862EBERLE914114291411422018-06-16
04050052015879EBERLE914115591411552018-06-16
04050052015886EBERLE914123591412352018-06-23
04050052015893EBERLE914124291412422018-06-23
04050052015909EBERLE914125591412552018-06-23
04050052015923EBERLE914133591413352018-06-23
04050052015930EBERLE914134291413422018-06-23
04050052015947EBERLE914135591413552018-06-23
04050052015954EBERLE914143591414352018-06-23
04050052015961EBERLE914144291414422018-06-23
04050052015985EBERLE914153591415352018-06-23
04050052015992EBERLE914154291415422018-06-23
04050052016005EBERLE914155591415552018-06-23
04050052016043EBERLE914185591418552018-06-23
04050052016050EBERLE914186591418652018-06-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506089589ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00198506089596ELMED INCORPORATEDELMED INCORPORATEDLHX2026-03-13
00885556919620R3Smith & Nephew, Inc.LHX2024-11-06
00885556919613R3Smith & Nephew, Inc.LHX2024-11-04
00191083047300AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047317AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047324AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047331AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047348AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047355AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047362AlloWedgeRti Surgical, Inc.LHX2024-10-14
00191083047379AlloWedgeRti Surgical, Inc.LHX2024-10-14
00840343722876GEN2SURGIX MEDICAL LLCLHX2024-06-28
08800017205267LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
08800068981486LOSPA Knee System, EXULT Knee SystemCorentec Co., LtdLHX2024-01-12
00840343720537GEN2SURGIX MEDICAL LLCLHX2023-12-15
00840343720957GEN2SURGIX MEDICAL LLCLHX2023-12-15
10889981321390SpecialsSeaspine Orthopedics CorporationLHX2023-12-06
00840343719326Gen2SURGIX MEDICAL LLCLHX2023-11-14
00840343719364Gen2SURGIX MEDICAL LLCLHX2023-11-14
00885556910757LegionSmith & Nephew, Inc.LHX2023-09-06
00840019967655Reform® Ti CT Modular MIS Pedicle Screw SystemPRECISION SPINE, INC.LHX2023-08-07
00885556832417Salto Talaris Total Ankle ProsthesisSmith & Nephew, Inc.LHX2023-08-02
10889981308315SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308322SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308339SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308346SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308353SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
10889981308438SpecialsSeaspine Orthopedics CorporationLHX2023-03-24
00850005827337GENESIS AWL/TAPPERGenesis Biologics, Inc.LHX2023-03-16