FDA.reportPublic FDA data

EBERLE

Primary DI
04050052015848
Brand
EBERLE
Company
Eberle GmbH & Co. KG
Model
9141125
Catalog number
9141125
Device description
Full Radius Resector 2,5
Published
2018-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092977000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092977000EBERLE SHAVER SYSTEM ACCESSORIESEfs Eberle Feinwerktechnische Systeme2010-09-29HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04050052029562PackageGS15In Commercial Distribution
04050052015848PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04050052029562040500520295624050052029562
04050052015848040500520158484050052015848

GMDN Terms#

Term, Definition table
TermDefinition
Arthroscopic shaver system blade, reusableA cutting device designed for use in a powered arthroscopic shaver system handpiece (not included) for bone and soft-tissue resection during arthroscopic surgery on a joint (e.g., a knee, shoulder, or ankle). It is locked into the handpiece, and typically consists of a small outer tube with a hub and a rotating inner tube with a connector that performs a rotational or reciprocating (back and forth) motion. It is typically made of high-grade stainless steel. This is a reusable device.

Regulatory Flags#

DUNS number
315919220
Device count
1
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
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
04050052016067EBERLE914195591419552018-06-23

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Primary DI, Brand, Company table
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00190776422059MillenniumAvalign Technologies, Inc.HRX2026-07-24
00190776422066MillenniumAvalign Technologies, Inc.HRX2026-07-24
10810004821085Spinal Needle SetCLARUS MEDICAL, LLCHRX2026-06-23
10810004821146Curved Cannula SetCLARUS MEDICAL, LLCHRX2026-06-23
00810004821101Digital SpineScope EndoscopeCLARUS MEDICAL, LLCHRX2026-06-22
10810004821122Spinal Introducer SetCLARUS MEDICAL, LLCHRX2026-06-22
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCHRX2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCHRX2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCHRX2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCHRX2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCHRX2026-06-03
00846338001629IEC Power Cord U.K. 220vELLIQUENCE, LLCHRX2026-06-03
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
10845854035559E9000Conmed CorporationHRX2026-03-24
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07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
B235MDK00020mild Device KitSTRYKER CORPORATIONHRX2024-06-19
08800038059313SYNTH™ STANDARDIMEDICOM CO., LTD.HRX2024-03-25