4701-048-000

GUDID 07613327175189

STRYKER CORPORATION

Birthing bed/table, powered
Primary Device ID07613327175189
NIH Device Record Key872b6a6e-7047-480c-bd64-f493c2c300e7
Commercial Distribution StatusIn Commercial Distribution
Version Model Number4701
Catalog Number4701-048-000
Company DUNS078470558
Company NameSTRYKER CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Operating and Storage Conditions

Storage Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Storage Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric PressureBetween 500 KiloPascal and 1060 KiloPascal
Handling Environment TemperatureBetween -4 Degrees Fahrenheit and 104 Degrees Fahrenheit
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS107613327175189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HDDTABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-24

Devices Manufactured by STRYKER CORPORATION

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07613327627664 - KNOTILUS+2024-03-15 2.9X12.5MM KNOTILUS+ HIP ANCHOR - PEEK
07613327627701 - KNOTILUS+2024-03-15 2.4X8.9MM KNOTILUS+ HIP ANCHOR - PEEK
07613327623796 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HIP
07613327623833 - KNOTILUS+2024-03-13 2.4X8.9MM DRILL, HARD BONE, HIP
07613327634686 - Iconix2024-03-12 Iconix DC Guide for 1.4mm anchor
07613327634693 - Iconix2024-03-12
07613327616675 - SPY2024-03-06

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