FDA.reportPublic FDA data

Compression Screw Instruments, For 4.0 mm Screws

Primary DI
10818674027479
Brand
Compression Screw Instruments, For 4.0 mm Screws
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
130400oss
Catalog number
THN00057
Published
2024-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HTWBit, Drill

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10818674027479PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081867402747910818674027479

GMDN Terms#

Term, Definition table
TermDefinition
Cannulated surgical drill bit, single-useA metal shaft intended to be mounted into an appropriate surgical power tool (e.g., a pneumatic reamer or drilling system handpiece with appropriate torque capacity) and rotated to bore into hard/tough tissues (e.g., bone, cartilage) in order to clear a channel of the same diameter as the shaft, typically for the insertion of a prosthetic device or other orthopaedic implant. It has a hollow centre so it can be fed over a drill guiding pin, and may be flexible; devices to assist the procedure (e.g., drill guiding pin, manual driver) may be included. This is a single-use 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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810128464045VersiTomic 2-Fluted Cannulated Reamer Ø11.0mm234-113-110124110st2026-08-03
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmTHN00720134070oss2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmTHN00721134100oss2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmTHN00685134070-01oss2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmTHN00684134100-01oss2026-08-23
10810128464311Hip 2.5 Grasper393400t393400t2026-03-19
10818674024324Hip Bone Pick 60°512404t512404t2026-03-19
10810128463918VersiTomic RR Retrograde Reamer 4.5 x 10.5mm0234-109-105145105st2026-08-03
10810128463925VersiTomic 2-Fluted Cannulated Reamer Ø5.0mm234-113-050124050st2026-08-03
10810128463932VersiTomic 2-Fluted Cannulated Reamer Ø5.5mm234-113-055124055st2026-08-03
10810128463949VersiTomic 2-Fluted Cannulated Reamer Ø6.0mm234-113-060124060st2026-08-03
10810128463956VersiTomic 2-Fluted Cannulated Reamer Ø6.5mm234-113-065124065st2026-08-03
10810128463963VersiTomic 2-Fluted Cannulated Reamer Ø7.0mm234-113-070124070st2026-08-03
10810128463970VersiTomic 2-Fluted Cannulated Reamer Ø7.5mm234-113-075124075st2026-08-03
10810128463987VersiTomic 2-Fluted Cannulated Reamer Ø8.0mm234-113-080124080st2026-08-03
10810128463994VersiTomic 2-Fluted Cannulated Reamer Ø8.5mm234-113-085124085st2026-08-03
10810128464007VersiTomic 2-Fluted Cannulated Reamer Ø9.0mm234-113-090124090st2026-08-03
10810128464014VersiTomic 2-Fluted Cannulated Reamer Ø9.5mm234-113-095124095st2026-08-03
10810128464021VersiTomic 2-Fluted Cannulated Reamer Ø10.0mm234-113-100124100st2026-08-03
10810128464038VersiTomic 2-Fluted Cannulated Reamer Ø10.5mm234-113-105124105st2026-08-03

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