FDA.reportPublic FDA data

Switchcut Reamer 4.5 x 6.0mm w/ Nitinol Passers

Primary DI
10810190013813
Brand
Switchcut Reamer 4.5 x 6.0mm w/ Nitinol Passers
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
C
Catalog number
110027674
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
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
10810190013813PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001381310810190013813

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
Manufacturing date on label
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10818674021545Switchcut Femoral Guide Arm Point110026880148400bsm2026-05-18
10818674021552Switchcut Tibial Guide Arm PCL110026881148500bsm2026-05-18
10810128463291Back Drill Guide Bullet ID 4.5mmS25-3001-T149000su2026-05-13
10810128463307Back Drill Guide Bullet ID 6.0mmS25-3002-T150000su2026-05-13
10810128463574Rasp Up Bend 20°S36-0013-T901131su2026-05-13
10810128463581Rasp Down Bend 20°S36-0024-T901141su2026-05-13
108101284636284.5mm Can. Full Thickness DrillS250045A113045su2026-05-13
108101284636357.0mm Can. Full Thickness DrillS25-7000-AT113070su2026-05-13
108101284636428.0mm Can. Full Thickness DrillS25-8000-AT113080su2026-05-13
108101284636599.0mm Can. Full Thickness DrillS25-9000-AT113090su2026-05-13
10810128463666Back Drill Femoral Guide Arm RightS25-3200-T148200su2026-05-13
10810128463673Back Drill Tibial Guide to PointS25-3300-T148300su2026-05-13
10810128463697Meniscal Root ArmS25-3600-T148600su2026-05-13
10810128462775OsteoTak ArthrexAR-1902611018ar2026-05-05
10818674022207Suture passe110038984254001bsm2026-04-14
10810128462997Champion+ Suture Passer3910-600-001382000st2026-04-07
10810128463000Champion+ Suture Passer 3910-600-002382100st2026-04-07
10810128463024Champion+ Suture Passer 3910-600-003S382300st2026-04-07
10810128463185Hip Bone Pick 60°512404t512404t2026-03-19
10810128463192Hip 2.5 Grasper393400t393400t2026-03-19

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