AccessGUDID - DEVICE: INTRABEAM® Cart (04049539101778)

GUDID

Device Identifier (DI) Information

Brand Name: INTRABEAM® Cart
Version or Model: 000000-1501-288
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Carl Zeiss Meditec AG

Primary DI Number: 04049539101778
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 342228620 *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?
59677	Intraoperative/postoperative therapeutic x-ray system	A mobile (on wheels) assembly of mains electricity (AC-powered) devices designed to produce low-energy x-rays used for therapeutic purposes, primarily in the treatment of cancer (e.g., breast, brain, skin) typically during or after an operation for tumour resection. It uses a miniature electronic X-ray source (50kV maximum) attached to one of various types and sizes of applicators specific to the clinical application (e.g., from within a resected breast tumour site). It typically consists of an x-ray source and an applicator mounted on a floor stand, verification tools, control unit, and user interface. It may be used in an operating room (OR) or other clinical setting.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KMN	Chair And Table, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: 278d4f10-16c6-4191-b936-5e475f189d69
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 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: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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