FDA.report

Gen2

Primary DI
00840343700263
Brand
Gen2
Company
SURGIX MEDICAL LLC
Model
G2E16660
Catalog number
G2E16660
Device description
HOUSE GELFOAM PRESS 12x15mm PL
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
LRCInstrument, Ent Manual Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRCInstrument, Ent Manual SurgicalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G277G2E166600PreviousHIBCC0
00840343700263PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840343700263008403437002638403437002630840343700263

GMDN Terms

TermDefinition
Gelfoam punchA manual instrument designed to punch circles of various sizes from a piece of Gelfoam (a sterile compressed gelatin sponge having haemostatic properties which usually absorbs completely within four to six weeks) typically used to help construct ossicular replacements during middle ear surgery. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length15Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
888-247-2477customerservice@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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