AccessGUDID - DEVICE: Protech Proguard (08054301890213)

GUDID

Device Identifier (DI) Information

Brand Name: Protech Proguard
Version or Model: SleeveM
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SleeveM
Company Name: EMERSON & CO SRL

Primary DI Number: 08054301890213
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 630558211 *Terms of Use

Device Description: Radiation Reducing Sleeves

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
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?
38369	Radiation shielding material, ionizing	A radiation protection device that attenuates ionizing radiation used to create barriers between an individual or a specific body part and a source of primary or scattered radiation used in medical or dental procedures. This group of devices includes a variety of materials, e.g., lead (Pb) bricks and sheets, lead-equivalent materials, leaded glass or plastic, tungsten (W), low molecular weight plastics or hydrogenous materials. Examples of use can be: lead bricks to build protective structures, lead sheets used in walls and doors, leaded glass or leaded-plastic sheets used in windows, mouldable lead-equivalent plastic or thermoplastic materials used to shield specific anatomical areas.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KPY	Shield, Protective, Personnel

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: in a dry place away from light and heat sources (below 35°).

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: dc3b4c3e-13c7-4ebb-bbba-1d977559619e
Public Version Date: April 16, 2018
Public Version Number: 1
DI Record Publish Date: March 15, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
08054301890954	3	08054301890213		In Commercial Distribution

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

Customer Contact

[?]

No Customer Contact currently defined

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