FDA.reportPublic FDA data

Durasul®

Primary DI
00889024168657
Brand
Durasul®
Company
Zimmer, Inc.
Model
4376-28-081
Catalog number
4376-28-081
Published
2017-10-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDIProsthesis, hip, semi-constrained, metal/polymer, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, CementedOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024168657PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024168657008890241686578890241686570889024168657

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 Diameter81Millimeter

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862661012N/AExactech, Inc.JDI2026-03-19
10885862661166N/AExactech, Inc.JDI2026-03-19
10885862661173N/AExactech, Inc.JDI2026-03-19
10885862663221N/AExactech, Inc.JDI2026-03-19
04719886912524Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912951Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912968Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912975Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912982Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886912999Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913002Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913019Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913026Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913033Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913040Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
04719886913064Locking CageUNITED ORTHOPEDIC CORP.JDI2026-03-03
00889024703292OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703315OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
00889024703339OSS™ Orthopedic Salvage SystemBiomet Orthopedics, LLCJDI2025-12-02
10885862658210EXACTECHExactech, Inc.JDI2025-11-14
10885862658326EXACTECHExactech, Inc.JDI2025-11-14
04719872162568UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872162926UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169017UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169024UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
04719872169031UCP StemUNITED ORTHOPEDIC CORP.JDI2025-09-15
00810008120859LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120866LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120873LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23
00810008120880LibertasMAXX ORTHOPEDICS, INC.JDI2025-07-23