FDA.reportPublic FDA data

Durasul®

Primary DI
00889024169166
Brand
Durasul®
Company
Zimmer, Inc.
Model
4377-28-049
Published
2017-10-23
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LPHPROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, POROUS UNCEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024169166PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024169166008890241691668890241691660889024169166

GMDN Terms#

Term, Definition table
TermDefinition
Non-constrained polyethylene acetabular linerA sterile, implantable component of a two-piece acetabulum prosthesis that is inserted into an acetabular shell prosthesis to provide the articulating surface with a femoral head prosthesis as part of a total hip arthroplasty (THA). It is made of polyethylene (includes hylamer, cross-linked polyethylene), and does not include a stabilizing component to limit the range of motion of the hip.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter49Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
056038268
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862660633N/AExactech, Inc.LPH2026-03-19
04580810066831Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810066909Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067784Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067807Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067821Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067845Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810067869Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068163Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068170Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068187Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068194Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068385Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068422Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068620Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068668Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068699Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068705Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068712Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068729Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068736Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068743Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068750Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068767Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068774Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068781Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068798Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068804Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068811Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27
04580810068828Initia Total Hip SystemKYOCERA MEDICAL CORPORATIONLPH2026-02-27