FDA.reportPublic FDA data

Gen2

Primary DI
00840343703912
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2N88841
Catalog number
G2N88841
Device description
"BAYONET CURETTE, BLACK HANDLE, 8.5"", ANG DOWN 3.0MM"
Published
2022-10-21
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
FZSCurette, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZSCurette, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G277G2N888410PreviousHIBCC0
00840343703912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343703912008403437039128403437039120840343703912

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length8.5Inch

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags#

DUNS number
080402644
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840343727437Gen2G2N99753G2N997532026-04-23
00840343727567Gen2G2G37293G2G372932026-04-23
00840343727574Gen2G2N99755G2N997552026-04-23
00840343727581Gen2G2C62489G2C624892026-04-23
00840343727451Gen2G2N49254G2N492542026-04-22
00840343727468Gen2G2G37278G2G372782026-04-22
00840343727475Gen2G2G37279G2G372792026-04-22
00840343727482Gen2G2G35954G2G359542026-04-22
00840343727499Gen2G2C62277G2C622772026-04-22
00840343727505Gen2G2C62434G2C624342026-04-22
00840343727512Gen2G2N48672TCG2N48672TC2026-04-22
00840343727529Gen2G2N87457G2N874572026-04-22
00840343727536Gen2G2N99517G2N995172026-04-22
00840343727543Gen2G2G37282G2G372822026-04-22
00840343727550Gen2G2O917144G2O9171442026-04-22
00840343727291GEN2G2E901343G2E9013432026-04-16
00840343727307GEN2G2E901344G2E9013442026-04-16
00840343727314GEN2G2E901345G2E9013452026-04-16
00840343727321GEN2G2E900935G2E9009352026-04-16
00840343727338GEN2G2N52380G2N523802026-04-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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