FDA.reportPublic FDA data

9.5mm Flexible Reamer

Primary DI
10810190016166
Brand
9.5mm Flexible Reamer
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
E
Catalog number
tg108095st
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
10810190016166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001616610810190016166

GMDN Terms#

Term, Definition table
TermDefinition
Ligament reconstruction instrument set, reusableA collection of surgical instruments intended to be used to prepare a joint for the reconstruction of damaged or torn ligaments, using a replacement device or tissue graft, during open or arthroscopic orthopaedic surgery. It typically consists of one or more guides, carriages, drill bits, reamers, burs, pushers, introducers, a staple impactor, and a surgical hammer. The set may be designed for specific joints, such as the shoulder or knee, and may assist in aligning the bone tunnels to allow isometric implantation of the ligament replacement device or graft. 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
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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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