AccessGUDID - DEVICE: Support cushion Breast BI 7 (04251269202667)

GUDID

Device Identifier (DI) Information

Brand Name: Support cushion Breast BI 7
Version or Model: 01
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 118770
Company Name: Noras MRI products GmbH

Primary DI Number: 04251269202667
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312844095 *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):	Yes
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?
40740	Medical-imaging cine projector	A device through which the developed film from cinematic (cine) cameras used in various medical imaging applications is intended to be retrospectively reviewed as motion pictures. Depending on the system design it will typically accommodate either 16 or 35-mm film formats and is typically used in conjunction with diagnostic x-ray systems, endoscopic systems, or diagnostic ultrasound systems. The basic components of a cine projector (also known as a movie or film projector) include a film transport mechanism, a light source with condenser optics, and imaging optics.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOS	Coil, Magnetic Resonance, Specialty

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K162651	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 70f14058-f1f1-49bf-a767-ed7ef1542a4f
Public Version Date: April 08, 2021
Public Version Number: 5
DI Record Publish Date: July 28, 2017

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: Yes
Serial Number: No
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +490931299270
Email: sales@noras.de

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