FDA.report

MultiCup™ Locking Screw

Primary DI
04048266010957
Brand
MultiCup™ Locking Screw
Company
Merete GmbH
Model
DIA 6.5 25
Catalog number
HF30225
Device description
MultiCup™ Locking Screw 6.5 25 TiAl6V4 ELI non-sterile
Published
2017-01-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented

Product Code Classifications

CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04048266010957PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04048266010957040482660109574048266010957

GMDN Terms

TermDefinition
Combination-material 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 of a combination of metal, ceramic, and/or polyethylene (PE); it may include fixation devices (e.g., screws) for attachment to the body.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
630-613-7182service@merete-medical.com
+1(630)869-1092service@merete-medical.com

Regulatory Flags

DUNS number
313267265
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
true
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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