FDA.reportPublic FDA data

GRAFTYS® DELIVERING GUN

Primary DI
03760177571655
Brand
GRAFTYS® DELIVERING GUN
Company
GRAFTYS
Model
GYINJECTS
Catalog number
GYINJECTS
Device description
GRAFTYS DELIVERY GUN
Published
2024-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
03760177571655PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03760177571655037601775716553760177571655

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic cement dispenserA syringe-like device intended for use in placing orthopaedic bone cement into surgical sites. Cement dispensers may be manually-operated or mounted in a powered unit that drives the piston down the syringe barrel. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
280930053
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03760177571396GRAFTYS® QUICKSET KIT5ccQSMKITUSV1Q52024-03-20
03760177571402GRAFTYS® QUICKSET KIT8ccQSMKITUSV1Q82024-03-20
03760177571419GRAFTYS® QUICKSET KIT16ccQSMKITUSV1Q162024-03-20
03760177571600GRAFTYS® QUICKSET5ccGYQSMUSV1Q52024-03-20
03760177571617GRAFTYS® QUICKSET8ccGYQSMUSV1Q82024-03-20
03760177571624GRAFTYS® QUICKSET16ccGYQSMUSV1Q162024-03-20

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