FDA.reportPublic FDA data

NA

Primary DI
07613327175189
Brand
NA
Company
STRYKER CORPORATION
Model
4701
Catalog number
4701-048-000
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
07613327175189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327175189076133271751897613327175189

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 Fahrenheit104 Degrees Fahrenheit

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
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

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
07613327175196NASTRYKER CORPORATIONHDD2016-09-24