AccessGUDID - DEVICE: NA (07613327175165)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 4701
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4701-045-000
Company Name: STRYKER CORPORATION

Primary DI Number: 07613327175165
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 078470558 *Terms of Use

Device Description: No description.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
15732	Birthing bed/table, powered	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HDD	TABLE, OBSTETRICAL, AC-POWERED (AND ACCESSORIES)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950889	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1060 KiloPascal
Storage Environment Atmospheric Pressure: between 500 and 1060 KiloPascal
Handling Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 104 Degrees Fahrenheit
Handling Environment Temperature: between -4 and 104 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d7595864-7b69-4abf-b654-ebfe2669ae7b
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES