FDA.reportPublic FDA data

Switchcut Reamer 4.5x6.5mm

Primary DI
10810190013660
Brand
Switchcut Reamer 4.5x6.5mm
Company
T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION
Model
C
Catalog number
110026886
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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
10810190013660PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081019001366010810190013660

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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10810128462386GFS Mini Tray3910-800-024tg52420st2026-02-01
10810128461792GFS Hohmann Retractor3910-800-017la524HB002st2026-01-18
10810128461808GFS Glenoid Lever, Double Prong3910-800-018la524HB004st2026-01-18
10810128461815GFS Subscapularis Spreader3910-800-019la524HB001st2026-01-18
10810128461822GFS Glenoid Drill3910-800-020la524130st2026-01-18
10810128461839GFS Glenoid Guide3910-800-021la524v00st2026-01-18
10810128461846GFS Small Probe3910-800-022la524pb0st2026-01-18
10810128461655GFS Switching Stick3910-800-003la900130st2026-01-15
10810128461662GFS Inline Coracoid Drill Guide3910-800-004la524t00st2026-01-15
10810128461679GFS Coracoid Drill3910-800-005la524p01st2026-01-15
10810128461686GFS Coracoid Top Hat Drill3910-800-006la524p00st2026-01-15
10810128461693GFS Top Hat Tap3910-800-007la524400st2026-01-15
10810128461709GFS Sharp Curved Osteotome3910-800-008la524800st2026-01-15
10810128461716GFS Subscapularis Channeler3910-800-009la524900st2026-01-15
10810128461747GFS Glenoid Offset Pin3910-800-012la524u00st2026-01-15
10810128461754GFS Coracoid Screw, 3.5mm3910-800-013la524f00st2026-01-15

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