FDA.reportPublic FDA data

NA

Primary DI
07613327169218
Brand
NA
Company
STRYKER CORPORATION
Model
4400
Catalog number
4400-324-002
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
07613327169218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327169218076133271692187613327169218

GMDN Terms#

Term, Definition table
TermDefinition
Newborn-infant bedA bed designed for newborn babies. It is usually an open rectangular receptacle, and mounted on a wheeled framework (trolley). It is padded or lined with appropriate bedding and used mostly as the general-purpose or standard baby bed in birthing departments. A source of additional heating may be provided to the newborn.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327524475Optablate97000151009700-015-1002022-09-23
07613327638233Omnicurve10320150001032-015-0002024-09-03
00857037006075LATERALATSYS24LATSYS242020-01-14
00857037006037LATERALATSYS20LATSYS202020-01-08
07613327060058Precision Ideal Eyes05028190100502-819-0102016-09-23
07613327006223ARIA48755700487557002019-11-20
07613327006919ES2 SPINAL SYSTEM48280082482800822019-11-20
07613327006926ES2 SPINAL SYSTEM48280083482800832019-11-20
07613327006940ES2 SPINAL SYSTEM48280086482800862019-11-20
07613327006957ES2 SPINAL SYSTEM48280087482800872019-11-20
07613327007114ES2 SPINAL SYSTEM48280311482803112019-11-25
07613327007558XIA 348237078482370782019-11-25
07613327007565XIA 348237079482370792019-11-25
07613327067088ACCULIF8003578003572016-09-24
07613327067095ACCULIF8003478003472016-09-24
07613327114799XIA 4.5 EVOLUTION48138140481381402019-11-21
07613327114812XIA 4.5 EVOLUTION48138011R48138011R2019-11-20
07613327114843XIA 4.5 EVOLUTION48138011L48138011L2019-11-20
07613327114850XIA 4.5 EVOLUTION48138101481381012019-11-21
07613327114874ES2 SPINAL SYSTEM48280178482801782019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327623284Double Tier Tray Outer ShellMAKO SURGICAL CORP.FMS2026-01-30
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