FDA.reportPublic FDA data

N/A

Primary DI
00643169669161
Brand
N/A
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
EX0815050
Device description
CURETTE EX0815050 LARGE ANGLED RING
Published
2017-09-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
00643169669161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169669161006431696691616431696691610643169669161

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
00199150002139N/A593250132026-07-16
00199150002146N/A593250162026-07-16
00199150015832INFINITY™ Occipitocervical Upper Thoracic System365370252026-07-16
00199150015849INFINITY™ Occipitocervical Upper Thoracic System365370302026-07-16
00199150015856INFINITY™ Occipitocervical Upper Thoracic System365370352026-07-16
00199150015863INFINITY™ Occipitocervical Upper Thoracic System365370402026-07-16
00199150015870INFINITY™ Occipitocervical Upper Thoracic System365370452026-07-16
00199150015887INFINITY™ Occipitocervical Upper Thoracic System365370502026-07-16
00199150015894INFINITY™ Occipitocervical Upper Thoracic System365370552026-07-16
00199150015900INFINITY™ Occipitocervical Upper Thoracic System365370602026-07-16
00199150015917INFINITY™ Occipitocervical Upper Thoracic System365370652026-07-16
00199150015924INFINITY™ Occipitocervical Upper Thoracic System365370702026-07-16
00199150015931INFINITY™ Occipitocervical Upper Thoracic System365370752026-07-16
00199150015948INFINITY™ Occipitocervical Upper Thoracic System365370802026-07-16
00199150015955INFINITY™ Occipitocervical Upper Thoracic System365370852026-07-16
00199150015962INFINITY™ Occipitocervical Upper Thoracic System365370902026-07-16
00199150015986INFINITY™ Occipitocervical Upper Thoracic System365371002026-07-16
00199150016006INFINITY™ Occipitocervical Upper Thoracic System365371102026-07-16
00199150016013INFINITY™ Occipitocervical Upper Thoracic System365371202026-07-16
00199150016037INFINITY™ Occipitocervical Upper Thoracic System365350602026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810168190464NAPACIFIC INSTRUMENTS, INC.HTF2026-07-06
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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