FDA.reportPublic FDA data

9.0mm Can. Full Thickness Drill

Primary DI
10810128463659
Brand
9.0mm Can. Full Thickness Drill
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
S25-9000-AT
Catalog number
113090su
Published
2026-05-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWKTrephine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810128463659PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081012846365910810128463659

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
534123013
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
10810128461426Back Drill 4.5 X 7.0mmS25-3070-T145070su2026-07-22
10810128461440Back Drill 4.5 X 8.0mmS25-3080-T145080su2026-07-22
10810128461457Back Drill 4.5 X 8.5mmS25-3085-T145085su2026-07-22
10810128461464Back Drill 4.5 X 9.0mmS25-3090-T145090su2026-07-22
10810128461471Back Drill 4.5 x 9.5mmS25-3095-T145095su2026-07-22
10810128461488Back Drill 4.5 X 10.0mmS25-3100-T145100su2026-07-22
10810128463338Back Drill 6.0 X 11.0mmS25-3110-T160110su2026-07-22
10810128464137WireS25-3004-T146000su2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmAR-6593-57Q159o570ar2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmAR-6593-59Q159o590ar2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmAR-6593-77Q159o770ar2026-07-21
10810128463154StayPort™ shoulder reusable obturator 9 mm x 70 mmAR-6593-97Q159o970ar2026-07-21
10810128463161StayPort™ shoulder reusable obturator 9 mm x 90 mmAR-6593-99Q159o990ar2026-07-21
10810128463178StayPort™ hip reusable adjustable obturator 9 mmAR-6593DT159o90ar2026-07-21
10810128462782StayPort™ Cannula 5 mm x 7 cmAR-6593-05-07159570ar2026-07-16
10810128462799StayPort™ Cannula 5 mm x 9 cmAR-6593-05-09159590ar2026-07-16
10810128462805StayPort™ Cannula 7 mm x 7 cmAR-6593-07-07159770ar2026-07-16
10810128462812StayPort™ Cannula 7 mm x 9 cmAR-6593-07-09159790ar2026-07-16
10810128462829StayPort™ Cannula 9 mm x 7 cmAR-6593-09-07159970ar2026-07-16
10810128462836StayPort™ Cannula 9 mm x 9 cmAR-6593-09-09159990ar2026-07-16

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