FDA.reportPublic FDA data

COSY

Primary DI
04047844111673
Brand
COSY
Company
SIGNUS Medizintechnik GmbH
Model
Reamer
Catalog number
CB0068
Device description
An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
Published
2023-03-15
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
04047844111673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04047844111673040478441116734047844111673

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49602391660info@signus.com

Regulatory Flags#

DUNS number
344203948
Device count
1
Premarket exempt
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
04047844130957DIPLOMATGuide wire, round/roundAC01602026-10-26
04047844130964DIPLOMATGuide wire, trocar/roundAC01612026-10-26
04047844005668KAINOS+Bone graft substitute, granules 2-3mmK001NT2015-09-24
04047844005675KAINOS+Bone graft substitute, granules 2-3mmK003NT2015-09-24
04047844005682KAINOS+Bone graft substitute, granules 2-3mmK004NT2015-09-24
04047844005699KAINOS+Bone graft substitute, granules 2-3mmK005NT2015-09-24
04047844005705KAINOS+Bone graft substitute, granules 2-3mmK006NT2015-09-24
04047844005712KAINOS+Bone graft substitute, insert for NUBICKNB0413142018-09-20
04047844005729KAINOS+Bone graft substitute, insert for NUBICKNB0513142018-09-20
04047844005736KAINOS+Bone graft substitute, insert for NUBICKNB0613142018-09-20
04047844005743KAINOS+Bone graft substitute, insert for NUBICKNB0713142018-09-20
04047844005750KAINOS+Bone graft substitute, insert for NUBICKNB0813142018-09-20
04047844005996KAINOS+Bone graft substitute, granules 1-2mmKS03NT2015-09-24
04047844006009KAINOS+Bone graft substitute, granules 1-2mmKS06NT2015-09-24
04047844023747KAINOS+Bone graft substitute, granulate 2-3mmK002NT2015-09-24
04047844130971DIPLOMATGuide wire, round/roundAC01622026-08-14
04047844130988DIPLOMATGuide wire, trocar/roundAC01632026-08-14
04047844066768DIPLOMATGuide wire, trocar/roundAC01262025-05-21
04047844042779DIPLOMATGuide wire obturatorAC0003-22022-06-09
04047844066751DIPLOMATGuide wire, round/roundAC01252022-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08437019739966WasherCap™ Surgical Instrument SetABANZA TECNOMED SL.HWL2023-06-01
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
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