FDA.reportPublic FDA data

N/A

Primary DI
00643169974616
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0117049
Device description
CURETTE EX0117049 RAKE STR LONG
Published
2017-09-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169974616PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169974616006431699746166431699746160643169974616

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

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Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28
00763000857820T2 STRATOSPHERE™ Expandable Corpectomy System43612052026-06-26
00763000858001T2 STRATOSPHERE™ Expandable Corpectomy System4361203002026-06-26
00643169190542CLYDESDALE PTC™ Spinal System49868402016-04-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190464NAPACIFIC INSTRUMENTS, INC.HTF2026-07-06
B803PS0099100A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991080ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099108A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991090ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099109A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991100ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0099110A0ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395900ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS03959000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS039590000ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395910ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395920ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395930ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395950ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0395960ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS0595940ORTHOMEDORTHO-MED, INC.HTF2026-06-26
B803PS00991010ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099101A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991020ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099102A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991030ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099103A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991040ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099104A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991050ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099105A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991060ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS0099106A0ORTHOMEDORTHO-MED, INC.HTF2026-06-25
B803PS00991070ORTHOMEDORTHO-MED, INC.HTF2026-06-25