AccessGUDID - DEVICE: MasterPeace (07350121950542)

GUDID

Device Identifier (DI) Information

Brand Name: MasterPeace
Version or Model: Table Shield Left
Commercial Distribution Status: In Commercial Distribution
Catalog Number: TS1050
Company Name: Texray AB

Primary DI Number: 07350121950542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 350597560 *Terms of Use

Device Description: Table Shield Left. To be placed at 1st operator position.

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?
64601	Radiation shielding table drape	A protective device intended to be placed on/draped over part of an operating table for a radiological examination during a surgical procedure (e.g. fluoroscopy using a C-arm) to shield attending healthcare personnel from unnecessary exposure to radiation. It commonly consists of a fluid-resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material which may in part be segmented into strips to allow passage of equipment under the table. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IWX	Barrier, Control Panel, X-Ray, Movable

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
Width: 90 Centimeter
Length: 100 Centimeter

Device Record Status

Public Device Record Key: 4af3efc6-06d3-42b6-874f-08a8b9a1f403
Public Version Date: March 06, 2025
Public Version Number: 1
DI Record Publish Date: February 26, 2025

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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