OvertureTi

Primary DI
00810129551808
Brand
OvertureTi
Company
Overture Resurfacing Inc
Model
PKG-90-OSP-360022
Published
2025-03-14
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810129551808PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810129551808008101295518088101295518080810129551808

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, single-useA collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width0

Regulatory Flags#

DUNS number
119105665
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
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
00810129550009OvertureTiPKG-90-OVR-1017252026-10-18
00810129550023OvertureTiPKG-90-OVR-1017352026-10-18
00810129550030OvertureTiPKG-90-OVR-1017402026-10-18
00810129550047OvertureTiPKG-90-OVR-1020302026-10-18
00810129550061OvertureTiPKG-90-OVR-1020402026-10-18
00810129550078OvertureTiPKG-90-OVR-1022302026-10-18
00810129550085OvertureTiPKG-90-OVR-1022352026-10-18
00810129550108OvertureTiPKG-90-OVR-1025352026-10-18
00810129550115OvertureTiPKG-90-OVR-1025402026-10-18
00810129550122OvertureTiPKG-90-OVR-1027352026-10-18
00810129550139OvertureTiPKG-90-OVR-1027402026-10-18
00810129551846OvertureTi90-S01-1022502025-07-23
00810129551723OvertureTiPKG-90-OSP-1017302025-03-14
00810129551730OvertureTiPKG-90-OSP-1020352025-03-14
00810129551747OvertureTiPKG-90-OSP-1022402025-03-14
00810129551754OvertureTiPKG-90-OSP-2000172025-03-14
00810129551761OvertureTiPKG-90-OSP-2000222025-03-14
00810129551778OvertureTiPKG-90-OSP-2000252025-03-14
00810129551785OvertureTiPKG-90-OSP-3600172025-03-14
00810129551792OvertureTiPKG-90-OSP-3600202025-03-14