FDA.report

DELTA TT Pro

Primary DI
08033390146098
Brand
DELTA TT Pro
Company
LIMACORPORATE SPA
Model
5553.14.441
Catalog number
5553.14.441
Device description
Acetabular Cup (Ti6Al4V) Dia. 44 mm, for Liners size SMALL
Published
2019-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous

Product Code Classifications

CodeDeviceSpecialtyClass
MBLProsthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, PorousOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08033390146098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08033390146098080333901460988033390146098

GMDN Terms

TermDefinition
Metallic acetabulum prosthesisA sterile implantable principal component of a total hip prosthesis (acetabular component) designed to replace or repair the acetabulum. The component is of a one-piece construction and is made entirely of metal [e.g., stainless steel, titanium (Ti)]. Devices designed to assist implantation/fixation (e.g., screws, surgical guides, trial prosthesis, anatomical models) may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Regulatory Flags

DUNS number
432066322
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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