FDA.reportPublic FDA data

NA

Primary DI
00889024134485
Brand
NA
Company
Zimmer, Inc.
Model
7804-45-02
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
00889024134485PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024134485008890241344858890241344850889024134485

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
00889024707382Persona Tensor Sizer Arm – LongSSI008513SSI0085132026-05-29
00889024707399Persona Tensor Sizer Arm – StdSSI008567SSI0085672026-05-29
00889024707405Persona Tensor Sizer BodySSI008566SSI0085662026-05-29
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

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
00889024134492NAZimmer, Inc.EAY2016-07-25
00889024134508NAZimmer, Inc.EAY2016-07-25