FDA.report

Gen2

Primary DI
00840343700607
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E900963
Catalog number
G2E900963
Device description
HOUSE FOOTPLATE CHISEL STR
Published
2022-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
JYEChisel, Middle-Ear

Product Code Classifications

CodeDeviceSpecialtyClass
JYEChisel, Middle-EarEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G277G2E9009630PreviousHIBCC0
00840343700607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343700607008403437006078403437006070840343700607

GMDN Terms

TermDefinition
Middle ear chiselA single-blade bevelled surgical instrument intended for use in cutting or contouring the bones of the middle ear, otological microsurgery, stapedotomy, and related ear/nose/throat (ENT) surgery. It is hand-held by the surgeon who will use a surgical mallet or hammer to manually impart an impacting force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp and can be either straight or angled. It is typically a one-piece instrument made of high-grade stainless steel. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-0477customerservice@surgixmedical.com

Regulatory Flags

DUNS number
080402644
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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