AccessGUDID - DEVICE: Positioning Cushion (00841439101384)

GUDID

Device Identifier (DI) Information

Brand Name: Positioning Cushion
Version or Model: 403024
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 403024
Company Name: MEDTEC, INC.

Primary DI Number: 00841439101384
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 103977526 *Terms of Use

Device Description: Rectangular cushion (30 x 24 x 5 cm)

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
61131	Radiological general body-part positioner	A device intended to facilitate adequate positioning and immobilization of a patient’s body part during diagnostic imaging procedures, image-guided surgical or interventional procedures, and/or radiation therapy procedures; it is not dedicated to a specific part of the body. The device is in the form of a frame, board, cushion, or preformed pad that may also be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LNH	System, nuclear magnetic resonance imaging
IYE	Accelerator, linear, medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K060737	000
K093738	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
Length: 30 Centimeter
Width: 24 Centimeter

Device Record Status

Public Device Record Key: 97a5b86b-0141-4c8f-bcdc-113a4792676f
Public Version Date: March 19, 2020
Public Version Number: 7
DI Record Publish Date: August 02, 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: Yes
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: +1(712)737-8688
Email: radiotherapy.complaints@civcort.com

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