FDA.reportPublic FDA data

NA

Primary DI
07613327175196
Brand
NA
Company
STRYKER CORPORATION
Model
4701
Catalog number
4701-045-015
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
HDDTABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDDTable, Obstetrical, Ac-Powered (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950889000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K950889000ADEL 5000Stryker Corp.1995-10-16HDD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327175196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327175196076133271751967613327175196

GMDN Terms#

Term, Definition table
TermDefinition
Birthing bed/table, poweredAn electrically-powered, adjustable device designed to support a pregnant woman's body in an appropriate position during labour and delivery, and may in addition be intended for other obstetrical examination or treatment procedures. This device may be referred to as a birthing/obstetric bed, table, couch, or chair, and will typically include, leg holders (stirrups), traction handles, a receptacle for afterbirth, and have facilities for the attachment of different accessories.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature-4 Degrees Fahrenheit104 Degrees Fahrenheit
Storage Environment Atmospheric Pressure500 KiloPascal1060 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Kelvin104 Degrees Kelvin

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
078470558
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613252450337ICONIX3910-500-5123910-500-5122015-08-26
07613252450344ICONIX3910-500-5223910-500-5222015-08-26
07613252450351ICONIX3910-500-5253910-500-5252015-08-26
07613252450368ICONIX3910-500-5323910-500-5322015-08-26
07613327176926ICONIX39105003123910-500-3122015-09-14
07613327176933ICONIX39105003223910-500-3222015-09-14
07613327283440ICONIX39105002123910-500-2122016-09-22
07613327298642Sonopet iQ55000083005500-008-3002019-05-03
07613327056952SERFAS Energy0279351100279-351-1002016-09-23
07613327056976SERFAS Energy0279351103279-351-1032016-09-23
07613327057027SERFAS Energy0279401100279-401-1002016-09-23
07613327057034SERFAS Energy02794012000279-401-2002016-09-23
07613327057041SERFAS Energy02793514000279-351-4002016-09-23
07613327058048CrossFlow045000000004500000002016-09-23
07613327294606NanoTackCAT02969CAT029692016-07-20
07613327643800NA79000620007900-062-0002025-12-19
07613327643824NA79001260007900-126-0002025-12-19
07613327643848NA79001250007900-125-0002025-12-19
00897146002025Adherus NUS-109NUS-1092016-12-19
00897146002018Adherus NUS-106NUS-1062015-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08592654444726VibwifeL I N E T spol. s r.o.HDD2024-10-23
08592654463659Ave 2L I N E T spol. s r.o.HDD2024-10-23
08592654455562Ave 2L I N E T spol. s r.o.HDD2024-06-20
08592654435540VibwifeL I N E T spol. s r.o.HDD2024-04-03
08592654422298Ave 2L I N E T spol. s r.o.HDD2023-12-11
08592654426142Ave 2L I N E T spol. s r.o.HDD2023-12-11
08592654397657Ave 2L I N E T spol. s r.o.HDD2023-05-05
08592654399682Ave 2L I N E T spol. s r.o.HDD2023-05-05
08592654801116Ave 2L I N E T spol. s r.o.HDD2022-04-14
08592654801079Ave 2L I N E T spol. s r.o.HDD2022-02-02
08592654801086Ave 2L I N E T spol. s r.o.HDD2022-02-02
08592654801055Ave 2L I N E T spol. s r.o.HDD2021-12-09
08592654801031Ave 2L I N E T spol. s r.o.HDD2021-05-14
08592654800966Ave 2L I N E T spol. s r.o.HDD2020-12-21
08592654801017Ave 2L I N E T spol. s r.o.HDD2020-12-21
08592654801024Ave 2L I N E T spol. s r.o.HDD2020-12-21
08592654800812AVE 2L I N E T spol. s r.o.HDD2020-05-22
08592654800829Ave 2L I N E T spol. s r.o.HDD2020-05-22
08592654800959Ave 2L I N E T spol. s r.o.HDD2020-05-22
08596307100014Ave 2L I N E T spol. s r.o.HDD2019-10-01
08592654800249Ave 2L I N E T spol. s r.o.HDD2019-06-07
08592654800188Ave 2L I N E T spol. s r.o.HDD2019-06-05
08592654800065Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800072Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800089Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800096Ave 2L I N E T spol. s r.o.HDD2018-04-10
08592654800102Ave 2L I N E T spol. s r.o.HDD2018-04-10
07613327175165NASTRYKER CORPORATIONHDD2016-09-24
07613327175172NASTRYKER CORPORATIONHDD2016-09-24
07613327175189NASTRYKER CORPORATIONHDD2016-09-24