FDA.reportPublic FDA data

OMNI Hip

Primary DI
00841690103240
Brand
OMNI Hip
Company
Omnilife Science, Inc
Model
304099
Catalog number
304099
Device description
Femoral CoCr Head 40 mm -3.5mm
Published
2015-11-27
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
MEHProsthesis, hip, semi-constrained, uncemented, metal/polymer, non-porous, calicum-phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841690103240PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841690103240008416901032408416901032400841690103240

GMDN Terms#

Term, Definition table
TermDefinition
Metallic femoral head prosthesisA sterile implantable artificial substitute for a diseased or injured femoral head that has an outer surface made of metal (e.g., titanium alloy). It is designed to be attached to the trunnion of a prosthetic femoral stem/shaft or a head/stem adaptor, and to articulate with an acetabulum prosthesis as part of a total hip arthroplasty (THA) or with a bipolar component as part of a partial hip arthroplasty. The device ranges in form from partially to fully spherical (ball-shaped) and is available in various sizes.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(800)448-6664CS@omnils.com

Regulatory Flags#

DUNS number
061339651
Device count
1
DM exempt
true
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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841690129943APEX Knee SystemKP-22613KP-226132021-07-08
00841690100805APEX CR KneeKC-1101LKC-1101L2015-11-27
00841690100812APEX CR KneeKC-1101RKC-1101R2015-11-27
00841690100829APEX CR KneeKC-1102LKC-1102L2015-11-27
00841690100836APEX CR KneeKC-1102RKC-1102R2015-11-27
00841690100843APEX CR KneeKC-1103LKC-1103L2015-11-27
00841690100850APEX CR KneeKC-1103RKC-1103R2015-11-27
00841690100867APEX CR KneeKC-1104LKC-1104L2015-11-27
00841690100874APEX CR KneeKC-1104RKC-1104R2015-11-27
00841690100881APEX CR KneeKC-1105LKC-1105L2015-11-27
00841690100898APEX CR KneeKC-1105RKC-1105R2015-11-27
00841690100904APEX CR KneeKC-1106LKC-1106L2015-11-27
00841690100911APEX CR KneeKC-1106RKC-1106R2015-11-27
00841690100928APEX CR KneeKC-1125LKC-1125L2015-11-27
00841690100935APEX CR KneeKC-1125RKC-1125R2015-11-27
00841690100942APEX CR KneeKC-1135LKC-1135L2015-11-27
00841690100959APEX CR KneeKC-1135RKC-1135R2015-11-27
00841690100966APEX CR KneeKC-1145LKC-1145L2015-11-27
00841690100973APEX CR KneeKC-1145RKC-1145R2015-11-27
00841690101000OMNI KneeKC-2201LKC-2201L2015-11-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862653697AlteonExactech, Inc.MEH2026-05-26
10885862653703AlteonExactech, Inc.MEH2026-05-26
10885862653710AlteonExactech, Inc.MEH2026-05-26
10885862653727AlteonExactech, Inc.MEH2026-05-26
10885862653734AlteonExactech, Inc.MEH2026-05-26
10885862653741AlteonExactech, Inc.MEH2026-05-26
10885862653758AlteonExactech, Inc.MEH2026-05-26
10885862653765AlteonExactech, Inc.MEH2026-05-26
10885862653772AlteonExactech, Inc.MEH2026-05-26
10885862653789AlteonExactech, Inc.MEH2026-05-26
10885862653796AlteonExactech, Inc.MEH2026-05-26
10885862653802AlteonExactech, Inc.MEH2026-05-26
10885862653819AlteonExactech, Inc.MEH2026-05-26
10885862653826AlteonExactech, Inc.MEH2026-05-26
10885862653833AlteonExactech, Inc.MEH2026-05-26
10885862653840AlteonExactech, Inc.MEH2026-05-26
10885862653857AlteonExactech, Inc.MEH2026-05-26
10885862653864AlteonExactech, Inc.MEH2026-05-26
10885862653871AlteonExactech, Inc.MEH2026-05-26
10885862653888AlteonExactech, Inc.MEH2026-05-26
10885862653895AlteonExactech, Inc.MEH2026-05-26
10885862653901AlteonExactech, Inc.MEH2026-05-26
10885862653918AlteonExactech, Inc.MEH2026-05-26
10885862653925AlteonExactech, Inc.MEH2026-05-26
10885862653932AlteonExactech, Inc.MEH2026-05-26
10885862653949AlteonExactech, Inc.MEH2026-05-26
10885862653956AlteonExactech, Inc.MEH2026-05-26
10885862653963AlteonExactech, Inc.MEH2026-05-26
10885862653970AlteonExactech, Inc.MEH2026-05-26
10885862653987AlteonExactech, Inc.MEH2026-05-26