FDA.reportPublic FDA data

WasherCap™ Surgical Instrument Set

Primary DI
08437019739966
Brand
WasherCap™ Surgical Instrument Set
Company
ABANZA TECNOMED SL.
Model
21
Device description
Reusable Surgical Instrument Set associated to the WasherCap™ Fixation System in order to facilitate its implantation during the surgical process.
Published
2023-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWLSet, Hollow Mill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWLSet, Hollow MillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08437019739966PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08437019739966084370197399668437019739966

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
(866) 550-7070customerservice@abanzamed.com

Regulatory Flags#

DUNS number
465714287
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08437019739744QuadLock™ Fixation System 9mmNA2026-01-14
08437019739751QuadLock™ Fixation System 10mmNA2026-01-14
08437019739768QuadLock™ Fixation System 11mmNA2026-01-14
08437019739430WasherCap™ Countersink 11 mm212026-03-30
08437019739447WasherCap™ Inserter 11mm212026-03-30
08437019739454WasherCap™ Countersink Positioner 11mm212026-03-30
08437019739461Inserter Coupling Screw 11mm212026-03-30
28437019739748QuadLock™ Fixation System 9mmNA2026-01-14
28437019739755QuadLock™ Fixation System 10mmNA2026-01-14
28437019739762QuadLock™ Fixation System 11mmNA2026-01-14
08437019739867WasherCap™ Fixation System 11mm212025-03-10
28437019739861WasherCap™ Fixation System 11mm212025-03-10
08437019739898WasherCap Mini Fixation system 3.5mm452025-02-25
08437019739904WasherCap Mini Fixation system 4.5mm452025-02-25
28437019739892WasherCap Mini Fixation system 3.5mm452025-02-25
28437019739908WasherCap Mini Fixation system 4.5mm452025-02-25
08437019739485WasherCap™ Inserter 7mm & 8mm212023-06-01
08437019739508WasherCap™ Inserter 9mm & 10mm212023-06-01
08437019739669WasherCap™ Countersink Positioner 7mm212023-06-01
08437019739676WasherCap™ Countersink Positioner 8mm212023-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973877662722RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662739RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662746RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662753RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662760RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662777RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662814RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662852RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877662869RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877663019RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667932RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667956RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667963RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667970RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
06973877667987RemoHipHangzhou Rejoin Mastin Medical Device Co., Ltd.HWL2023-05-22
04047844111673COSYSIGNUS Medizintechnik GmbHHWL2023-03-15
07613327417289INSTRUMENTHowmedica Osteonics Corp.HWL2018-06-01
00190776032548AvalignAvalign Technologies, Inc.HWL2017-05-01
00190776032555AvalignAvalign Technologies, Inc.HWL2017-05-01
00889024023215NAZimmer, Inc.HWL2016-07-26
00889024023222NAZimmer, Inc.HWL2016-07-26
00889024023239NAZimmer, Inc.HWL2016-07-26
00889024023246NAZimmer, Inc.HWL2016-07-26
00889024039742ZMS®Zimmer, Inc.HWL2016-07-26