FDA.reportPublic FDA data

Polar

Primary DI
00885556878590
Brand
Polar
Company
Smith & Nephew, Inc.
Model
E0017700-4
Catalog number
E0017700-4
Device description
AGGRESSIVE POLARSTEM BROACH 2
Published
2022-05-05
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
HTQBROACH

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTQBroachOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00885556878590PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00885556878590008855568785908855568785900885556878590

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
03596010619952NA72201597722015972015-08-29
03596010619969NA72201598722015982015-08-29
00885556572351NA72201597S72201597S2017-06-15
00885556572368NA72201598S72201598S2017-06-15
00885556830543PyroCarbon Modular Radial HeadTRL-310-01TRL-310-012026-09-24
00885556830550PyroCarbon Modular Radial HeadTRL-310-02TRL-310-022026-09-24
00885556830567PyroCarbon Modular Radial HeadTRL-310-03TRL-310-032026-09-24
00885556830574PyroCarbon Modular Radial HeadTRL-310-04TRL-310-042026-09-24
00885556839690Total Foot System 2CSA-800-06CSA-800-062026-09-24
00885556839706Total Foot System 2CSA-800-07CSA-800-072026-09-24
00885556854778Cadence Total Ankle SystemCSA-1020-0014CSA-1020-00142026-09-24
00885556859636Titan Modular Shoulder SystemCSA092009CSA0920092026-09-24
00885556859643Titan Modular Shoulder SystemCSA092010CSA0920102026-09-24
00885556859650Titan Modular Shoulder SystemCSA092011CSA0920112026-09-24
00885556859698Titan Modular Shoulder SystemCSA-0920-15CSA-0920-152026-09-24
00885556859704Titan Modular Shoulder SystemCSA-0920-16CSA-0920-162026-09-24
00885556859711Titan Modular Shoulder SystemCSA-0920-17CSA-0920-172026-09-24
00885556859728Titan Modular Shoulder SystemCSA-0920-18CSA-0920-182026-09-24
00885556859735Titan Modular Shoulder SystemCSA-0920-19CSA-0920-192026-09-24
00885556859742Titan Modular Shoulder SystemCSA-0920-20CSA-0920-202026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692803Klassic Blade Femoral Broach, Line-To-Line, size 0TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692810Klassic Blade Femoral Broach, Line-To-Line, size 1TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692827Klassic Blade Femoral Broach, Line-To-Line, size 2TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692834Klassic Blade Femoral Broach, Line-To-Line, size 3TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692841Klassic Blade Femoral Broach, Line-To-Line, size 4TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692858Klassic Blade Femoral Broach, Line-To-Line, size 5TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692865Klassic Blade Femoral Broach, Line-To-Line, size 6TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692872Klassic Blade Femoral Broach, Line-To-Line, size 7TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692889Klassic Blade Femoral Broach, Line-To-Line, size 8TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692896Klassic Blade Femoral Broach, Line-To-Line, size 9TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692902Klassic Blade Femoral Broach, Line-To-Line, size 10TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692919Klassic Blade Femoral Broach, Line-To-Line, size 11TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00810094692926Klassic Blade Femoral Broach, Line-To-Line, size 12TOTAL JOINT ORTHOPEDICS, INC.HTQ2026-07-27
00840314269751gSourceGSOURCE LLCHTQ2025-06-16
00885556871447AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871454AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871461AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871478AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556871485AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-06-19
00885556811924AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811931AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811948AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811955AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556811962AETOS Shoulder SystemSmith & Nephew, Inc.HTQ2023-02-03
00885556856505Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856512Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856529Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856536Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856543Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02
00885556856550Ascension MCP Joint ReplacementSmith & Nephew, Inc.HTQ2023-02-02