FDA.reportPublic FDA data

Double Tier Tray Outer Shell

Primary DI
07613327623284
Brand
Double Tier Tray Outer Shell
Company
MAKO SURGICAL CORP.
Model
700002606011
Catalog number
700002606011
Published
2026-01-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FMSBED, PEDIATRIC OPEN HOSPITAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMSBed, Pediatric Open HospitalGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327623284PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327623284076133276232847613327623284

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
175239677
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
07613327623260Mako7000026060217000026060212026-05-29
07613327594829Common Shoulder Driver1906601906602026-05-21
07613327595543Mako2906512906512026-05-21
07613327579888N/A7000015775787000015775782024-08-07
07613327595505Mako Glenoid RetractorSmall1906652026-01-08
07613327625868INSTRUMENT7000021128907000021128902024-10-04
07613327624304NA2299992299992024-09-18
07613327395280NA2199992199992020-12-15
00848486021702RIO2038662038662016-09-24
00848486022211NA2071102071102016-09-24
00848486023249NA2099272099272016-09-24
00848486030407NA2099992099992016-09-24
07613327627725MakoShoulder 1.0+TKA 2.0.1+TKA 1.0.3+THA 4.17000028873152026-03-10
07613327683653Shoulder 1.5 Installation Disk7000043787467000043787462026-03-03
00848486000349RESTORIS180320-2180320-22015-09-24
00848486000356RESTORIS180320-1180320-12015-09-24
00848486000370RESTORIS180320-4180320-42015-09-24
00848486000387RESTORIS180320-5180320-52015-09-24
00848486000394RESTORIS180320-6180320-62015-09-24
00848486000400RESTORIS1804021804022015-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654433973Tom 2L I N E T spol. s r.o.FMS2024-02-23
00850022426773C1983CGNOVUM MEDICAL PRODUCTS INCFMS2024-02-14
00850022426766C2080FWCRNOVUM MEDICAL PRODUCTS INCFMS2024-01-12
08592654351956Tom 2L I N E T spol. s r.o.FMS2023-12-11
08592654389690Tom 2L I N E T spol. s r.o.FMS2023-04-14
00850022426650C2083CGNOVUM MEDICAL PRODUCTS INCFMS2023-02-16
00850022426643C2072CLNOVUM MEDICAL PRODUCTS INCFMS2022-11-17
08592654376386Tom 2L I N E T spol. s r.o.FMS2022-11-16
00850022426636C1981CGTNOVUM MEDICAL PRODUCTS INCFMS2022-11-15
08592654289884Tom 2L I N E T spol. s r.o.FMS2022-04-29
08592654353882Tom 2L I N E T spol. s r.o.FMS2022-04-29
08592654348000Tom 2L I N E T spol. s r.o.FMS2022-02-28
08592654345450Tom 2L I N E T spol. s r.o.FMS2022-01-21
00850022426490C2081CLNOVUM MEDICAL PRODUCTS INCFMS2021-05-18
00850022426346E1981CL-3SDNOVUM MEDICAL PRODUCTS INCFMS2021-03-11
00850022426339C1970CLTNOVUM MEDICAL PRODUCTS INCFMS2021-03-08
00850022426315E2065FWCR-18UNOVUM MEDICAL PRODUCTS INCFMS2021-03-02
00850022426117C2081CGTNOVUM MEDICAL PRODUCTS INCFMS2021-01-26
07613327282702HAVASUSTRYKER CORPORATIONFMS2021-01-20
07613327282740HAVASUSTRYKER CORPORATIONFMS2021-01-20
00850925007802E2072CLTNOVUM MEDICAL PRODUCTS INCFMS2020-05-27
00850925007796E2092CGNOVUM MEDICAL PRODUCTS INCFMS2020-04-01
00850925007789E1982CG-CHNOVUM MEDICAL PRODUCTS INCFMS2020-03-25
00850925007765115E-H-ANOVUM MEDICAL PRODUCTS INCFMS2020-01-24
08592654210970Tom 2L I N E T spol. s r.o.FMS2019-11-07
00850925007758E1980FWCR-3SDNOVUM MEDICAL PRODUCTS INCFMS2019-10-29
00850925007741C2082CLTNOVUM MEDICAL PRODUCTS INCFMS2019-09-16
00850925007734C1970CLNOVUM MEDICAL PRODUCTS INCFMS2019-09-05
00850925007727E2083CGNOVUM MEDICAL PRODUCTS INCFMS2019-06-10
B751PDLFT0PediaLiftPEDIALIFT LLCFMS2019-05-07