FDA.reportPublic FDA data

NA

Primary DI
04042409398896
Brand
NA
Company
aap Implantate AG
Model
IU 3202-16
Device description
Cannulated reamer proximal (cone), ø16
Published
2018-02-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409398896PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409398896040424093988964042409398896

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
328420633
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
04042409035807NAIP 0104-002018-02-28
04042409035845NAIP 0104-012018-02-28
04042409002939NAIP 8403-002018-02-28
04042409036170NAIP 2505-002018-02-28
04042409207273NAIP 8405-002018-02-28
04042409228995NAIP 8405-502018-02-28
04042409363337NAIP 2506-002018-02-28
04042409387555LOQTEQ®IU 8166-042018-02-28
04042409202711LOQTEQ®PG 3555-04-2PG 3555-04-22016-08-18
04042409202728LOQTEQ®PG 3555-05-2PG 3555-05-22016-08-18
04042409202735LOQTEQ®PG 3555-06-2PG 3555-06-22016-08-18
04042409202742LOQTEQ®PG 3555-07-2PG 3555-07-22016-08-18
04042409202766LOQTEQ®PG 3555-08-2PG 3555-08-22016-08-18
04042409202773LOQTEQ®PG 3555-09-2PG 3555-09-22016-08-18
04042409202797LOQTEQ®PG 3555-10-2PG 3555-10-22016-08-18
04042409202803LOQTEQ®PG 3555-11-2PG 3555-11-22016-08-18
04042409202810LOQTEQ®PG 3555-12-2PG 3555-12-22016-08-18
04042409202827LOQTEQ®PG 3555-14-2PG 3555-14-22016-08-18
04042409202834LOQTEQ®PG 3555-16-2PG 3555-16-22016-08-18
04042409202841LOQTEQ®PG 3555-18-2PG 3555-18-22016-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800017270302BENCOXCorentec Co., LtdHTO2026-04-02
08800017270319BENCOXCorentec Co., LtdHTO2026-04-02
08800017270326BENCOXCorentec Co., LtdHTO2026-04-02
08800017270333BENCOXCorentec Co., LtdHTO2026-04-02
08800017270340BENCOXCorentec Co., LtdHTO2026-04-02
08800017270364BENCOXCorentec Co., LtdHTO2026-04-02
08800017270388BENCOXCorentec Co., LtdHTO2026-04-02
08800017270401BENCOXCorentec Co., LtdHTO2026-04-02
08800017270425BENCOXCorentec Co., LtdHTO2026-04-02
08800017270449BENCOXCorentec Co., LtdHTO2026-04-02
08800017270463BENCOXCorentec Co., LtdHTO2026-04-02
08800017270470BENCOXCorentec Co., LtdHTO2026-04-02
08800017270487BENCOXCorentec Co., LtdHTO2026-04-02
08800017270500BENCOXCorentec Co., LtdHTO2026-04-02
08800017270524BENCOXCorentec Co., LtdHTO2026-04-02
08800017270548BENCOXCorentec Co., LtdHTO2026-04-02
08800017270562BENCOXCorentec Co., LtdHTO2026-04-02
08800017270579BENCOXCorentec Co., LtdHTO2026-04-02
08800017270586BENCOXCorentec Co., LtdHTO2026-04-02
08800017270593BENCOXCorentec Co., LtdHTO2026-04-02
08800017270609BENCOXCorentec Co., LtdHTO2026-04-02
08800017270616BENCOXCorentec Co., LtdHTO2026-04-02
08800017270623BENCOXCorentec Co., LtdHTO2026-04-02
07640187918410TRIGEN MAX ENTRY REAMER 12.5 MM, HALL-JACOBSMPS Micro Precision Systems AGHTO2026-02-24
G079C5090000070Golden Isles Pedicle Screw SystemIntelivation, LLCHTO2022-09-23
07640187910407LINK InstrumentWALDEMAR LINK GmbH & Co. KGHTO2019-08-05