FDA.reportPublic FDA data

Polar

Primary DI
00885556910191
Brand
Polar
Company
Smith & Nephew, Inc.
Model
E0018105-1
Catalog number
E0018105-1
Device description
DA ANGLED CURETTE
Published
2023-08-02
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
00885556910191PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556910191008855569101918855569101910885556910191

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags#

DUNS number
045483575
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
03596010479235ECHELON71342011713420112015-09-28
03596010479266ECHELON71342014713420142015-09-28
03596010479273ECHELON71342015713420152015-09-28
03596010479297ECHELON71342017713420172015-09-28
03596010479303ECHELON71342018713420182015-09-28
03596010479310ECHELON71342019713420192015-09-28
03596010479341ECHELON71343012713430122015-09-28
03596010459749SYNERGY71309109713091092015-08-30
03596010459756SYNERGY71309110713091102015-08-30
03596010459787SYNERGY71309113713091132015-08-30
03596010459794SYNERGY71309114713091142015-08-30
03596010459817SYNERGY71309116713091162015-08-30
03596010459831SYNERGY71309118713091182015-08-30
03596010479259ECHELON71342013713420132015-09-28
03596010479280ECHELON71342016713420162015-09-28
03596010479358ECHELON71343013713430132015-09-28
03596010479365ECHELON71343014713430142015-09-28
03596010479389ECHELON71343016713430162015-09-28
03596010479396ECHELON71343017713430172015-09-28
03596010479402ECHELON71343018713430182015-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
10653160279853CenturionCENTURION MEDICAL PRODUCTS CORPORATIONHTF2022-01-01