FDA.reportPublic FDA data

N/A

Primary DI
00643169652071
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0515061
Device description
CURETTE EX0515061 RAKE STR
Published
2017-09-29
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
00643169652071PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169652071006431696520716431696520710643169652071

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00721902298431TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0182015-08-18
00721902298448TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0202015-08-18
00721902298455TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0222015-08-18
00721902298462TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0242015-08-19
00721902298479TOWNLEY™ Transfacetpedicular Screw Fixation SystemX873-0262015-08-18
00763000704483MSB CAPSTONE CONTROL™ Spinal System40016272026-07-20
00763000879556MSB Reusable Instruments5210-10222026-07-20
00763000992439MSB INFINITY OCT SystemG365PT40262026-07-20
00763000992446MSB INFINITY OCT SystemG365PT40282026-07-20
00763000993092MSB INFINITY OCT SystemG36555352026-07-20
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19

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