FDA.reportPublic FDA data

N/A

Primary DI
00840239800671
Brand
N/A
Company
ADVANCED RESEARCH MEDICAL LLC
Model
A-06-2
Catalog number
A-06-2
Device description
XL-Flexible Curette - Outer
Published
2024-04-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840239800671PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840239800671008402398006718402398006710840239800671

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
(612) 440-1865info@advresmed.com

Regulatory Flags#

DUNS number
117201206
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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Primary DI, Brand, Model table
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00850014575168Lumbar Interbody Fusion System (OLLIF)01-301001-30102019-12-16
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00850014575212Lumbar Interbody Fusion System (OLLIF)01-301501-30152019-12-16
00850014575229Lumbar Interbody Fusion System (OLLIF)01-331501-33152019-12-16
00850014575236Lumbar Interbody Fusion System (OLLIF)01-331401-33142019-12-16
00850014575243Lumbar Interbody Fusion System (OLLIF)01-331301-33132019-12-16
00850014575250Lumbar Interbody Fusion System (OLLIF)01-331201-33122019-12-16
00850014575267Lumbar Interbody Fusion System (OLLIF)01-331101-33112019-12-16

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