AccessGUDID - DEVICE: CombiMax (B884S06211100R0)

GUDID

Device Identifier (DI) Information

Brand Name: CombiMax
Version or Model: Right Hand
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S 0621 1100RH
Company Name: Pausch, L.L.C.

Primary DI Number: B884S06211100R0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080365572 *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?
65313	Diagnostic X-ray system positioning frame	An electrically-powered component of a diagnostic x-ray system intended to be placed on the floor to position and support a patient, an x-ray tube assembly, and an image receptor assembly (bucky) during a diagnostic x-ray procedure. It typically consists of a patient table, floor stands for the x-ray tube and image receptor, and controls. The table and floor stands may be moved and/or tilted; the image receptor may be included, however the x-ray tube is not included.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IZZ	Table, Radiographic, Non-Tilting, Powered

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: 78c9d830-293d-4011-981c-3eaf3382b5d6
Public Version Date: January 05, 2023
Public Version Number: 1
DI Record Publish Date: December 28, 2022

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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