FDA.reportPublic FDA data

NA

Primary DI
00889024134492
Brand
NA
Company
Zimmer, Inc.
Model
7804-45-03
Published
2016-07-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAYLIGHT, FIBER OPTIC, DENTAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAYLight, Fiber Optic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024134492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024134492008890241344928890241344920889024134492

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024701281Identity® Shoulder System11007733110077332026-06-10
00889024701298Identity® Shoulder System11007734110077342026-06-10
00889024701304Identity® Shoulder System11007735110077352026-06-10
00889024701311Identity® Shoulder System11007736110077362026-06-10
00889024701328Identity® Shoulder System11007737110077372026-06-10
00889024701335Identity® Shoulder System11007738110077382026-06-10
00889024701342Identity® Shoulder System11007739110077392026-06-10
00889024701359Identity® Shoulder System11007740110077402026-06-10
00889024701366Identity® Shoulder System11007741110077412026-06-10
00889024701373Identity® Shoulder System11007742110077422026-06-10
00889024701380Identity® Shoulder System11007743110077432026-06-10
00889024701397Identity® Shoulder System11007744110077442026-06-10
00889024701403Identity® Shoulder System11007745110077452026-06-10
00889024701410Identity® Shoulder System11007746110077462026-06-10
00889024701427Identity® Shoulder System11007747110077472026-06-10
00889024701434Identity® Shoulder System11007748110077482026-06-10
00889024701441Identity® Shoulder System11007749110077492026-06-10
00889024701458Identity® Shoulder System11007750110077502026-06-10
00889024701465Identity® Shoulder System11007751110077512026-06-10
00889024701472Identity® Shoulder System11007752110077522026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
0081400502148503BA-FOQuality Aspirators, Inc.EAY2025-02-27
0081400502150803BAT-FOQuality Aspirators, Inc.EAY2025-02-27
0081400502248276R-FOQuality Aspirators, Inc.EAY2025-02-27
00814005023120HDPQuality Aspirators, Inc.EAY2025-02-27
00814005023267LG316-7Quality Aspirators, Inc.EAY2025-02-27
00814005023274LG316-8Quality Aspirators, Inc.EAY2025-02-27
00814005023281LG316-9Quality Aspirators, Inc.EAY2025-02-27
00814005023380MDPQuality Aspirators, Inc.EAY2025-02-27
00814005023403Minn-SQuality Aspirators, Inc.EAY2025-02-27
00814005023489PE-FOQuality Aspirators, Inc.EAY2025-02-27
00814005023748Seldin 23-FOQuality Aspirators, Inc.EAY2025-02-27
00814005024349HDP-02Quality Aspirators, Inc.EAY2025-02-27
00814005024363MR-FOQuality Aspirators, Inc.EAY2025-02-27
04719883751348APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-26
04719883751362APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-26
04719883751331APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-21
04719883751355APOZAAPOZA ENTERPRISE CO., LTD.EAY2023-06-21
D2483550861FOCU-TIP NO.9.5 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D2483550871FOCU-TIP NO.8 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D2483550881FOCU-TIP NO.9 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D2483550891FOCU-TIP NO.12 (SET/2) WHITE LIGHT INTENSIFYING TIPHAGER WORLDWIDE, INC.EAY2023-05-12
D836PSLFH9LED Curing LightDENT ZAR, INC.EAY2022-03-07
04560218680945DENTECHDENTECH CORPORATIONEAY2020-09-24
D798LEDBAT0LED BatteryRELIANCE ORTHODONTIC PRODUCTS INCEAY2016-09-20
D798LEDPS0LED PowerslotRELIANCE ORTHODONTIC PRODUCTS INCEAY2016-09-20
00889024133396NAZimmer, Inc.EAY2016-07-25
00889024134317NAZimmer, Inc.EAY2016-07-25
00889024134478NAZimmer, Inc.EAY2016-07-25
00889024134485NAZimmer, Inc.EAY2016-07-25
00889024134508NAZimmer, Inc.EAY2016-07-25