FDA.reportPublic FDA data

NA

Primary DI
00889024134508
Brand
NA
Company
Zimmer, Inc.
Model
7804-45-04
Catalog number
00-7804-045-04
Published
2016-07-25
Public version status
Update
Distribution status
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
00889024134508PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024134508008890241345088890241345080889024134508

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
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.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
00889024702356OsseoFit00-5381-017-1100-5381-017-112026-10-28
00889024702363OsseoFit00-5381-017-1200-5381-017-122026-10-28
00889024702370OsseoFit00-5381-017-1300-5381-017-132026-10-28
00889024702387OsseoFit00-5381-017-1400-5381-017-142026-10-28
00889024702394OsseoFit00-5381-017-1500-5381-017-152026-10-28
00889024702400OsseoFit00-5381-017-1600-5381-017-162026-10-28
00889024702417OsseoFit00-5381-017-2100-5381-017-212026-10-28
00889024702424OsseoFit00-5381-017-2200-5381-017-222026-10-28
00889024702431OsseoFit00-5381-017-2300-5381-017-232026-10-28
00889024702448OsseoFit00-5381-017-2400-5381-017-242026-10-28
00889024702455OsseoFit00-5381-017-2500-5381-017-252026-10-28
00889024702462OsseoFit00-5381-017-2600-5381-017-262026-10-28
00889024702233OsseoFit00-5381-008-0500-5381-008-052026-10-27
00889024702240OsseoFit00-5381-008-0600-5381-008-062026-10-27
00889024702257OsseoFit00-5381-013-0000-5381-013-002026-10-27
00889024702264OsseoFit00-5381-013-1000-5381-013-102026-10-27
00889024702271OsseoFit00-5381-013-1100-5381-013-112026-10-27
00889024702295OsseoFit00-5381-013-1300-5381-013-132026-10-27
00889024702301OsseoFit00-5381-014-0000-5381-014-002026-10-27
00889024702318OsseoFit00-5381-014-0100-5381-014-012026-10-27

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
00889024134492NAZimmer, Inc.EAY2016-07-25