FDA.reportPublic FDA data

NA

Primary DI
10886982292681
Brand
NA
Company
Synthes GmbH
Model
03.045.031
Catalog number
03045031
Device description
CURETTE FOR XL25
Published
2020-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334167996Direct MarkingGS10
10886982292681PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334167996076123341679967612334167996
1088698229268110886982292681

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982030054LCP02.108.412021084122015-09-14
10886982033079VA-LCP02.112.049021120492015-09-14
10886982042590LCP02.124.213021242132015-09-14
10886982055552NA02.221.002S02221002S2015-09-14
10886982055569NA02.221.003S02221003S2015-09-14
10886982055583NA02.221.004S02221004S2015-09-14
10886982076748NA03.221.015032210152016-12-31
10886982076762NA03.221.016032210162016-12-31
10886982076779NA03.221.017032210172016-12-31
10886982120960NA04.221.002S04221002S2015-09-14
10886982120977NA04.221.003S04221003S2015-09-14
10886982120991NA04.221.004S04221004S2015-09-14
10886982182494NA298.800.01S29880001S2015-09-14
10886982182500NA298.801.01S29880101S2015-09-14
10886982198112NA391.1033911032016-12-31
10886982198129NA391.1043911042016-12-31
10886982198136NA391.1053911052016-12-31
10886982198143NA391.1063911062016-12-31
10886982198150NA391.1073911072016-12-31
10886982198167NA391.1083911082016-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B7684612300Buxton BioMedicalBuxton Biomedical IncHTF2026-06-02
10653160384816CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2025-01-25
10653160382133CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-11-08
10653160382140CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-11-08
10653160374862CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2024-05-18
08806395489848PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489855PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
08806395489862PYXIS 3D Titanium Cage SystemGS Medical Co., Ltd.HTF2024-01-09
10653160357506CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2023-01-13
07898506841431QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506845439QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506848447QuinelatoSchobell Industrial LtdaHTF2023-01-10
07898506841929QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506841967QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506848935QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506848942QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849260QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506849314QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506853793QuinelatoSchobell Industrial LtdaHTF2023-01-09
07898506853809QuinelatoSchobell Industrial LtdaHTF2023-01-09
EZPF41891040HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-16
EZPF4185501ZS0HELMUT ZEPFHelmut Zepf Medizintechnik GmbHHTF2022-12-08
10653160351368CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351382CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351399CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351429CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160351474CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-03-21
10653160307334CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-02
10653160278795CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01
10653160279846CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01