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

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.

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
04047844129418DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-951202026-07-13
04047844129425DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450252026-07-13
04047844129432DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450302026-07-13
04047844129449DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450352026-07-13
04047844129456DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450402026-07-13
04047844129463DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450452026-07-13
04047844129470DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450502026-07-13
04047844129487DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450552026-07-13
04047844129494DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-450602026-07-13
04047844129500DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550252026-07-13
04047844129517DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550302026-07-13
04047844129524DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550352026-07-13
04047844129531DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550402026-07-13
04047844129548DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550452026-07-13
04047844129555DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550502026-07-13
04047844129562DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550552026-07-13
04047844129579DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-550602026-07-13
04047844129586DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650252026-07-13
04047844129593DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650302026-07-13
04047844129609DIPLOMAT FTPedicle screw w/o tulip, cannulated, polyaxialAB0222-650352026-07-13

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