AccessGUDID - DEVICE: AADCO (00840348526219)

GUDID

Device Identifier (DI) Information

Brand Name: AADCO
Version or Model: LP-212
Commercial Distribution Status: In Commercial Distribution
Catalog Number: LP-212
Company Name: AADCO MEDICAL, INC.

Primary DI Number: 00840348526219
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 153603204 *Terms of Use

Device Description: X-1 RADIATION RESISTANT GLOVES SIZE 9

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:	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?
38366	Partial-hand radiation shield	A flat pad with a strap or partial glove assembly used to shield only a portion of the hand or fingers of the wearer from unnecessary exposure to primary and scattered radiation associated with diagnostic and therapeutic medical procedures. Some types can be designed to shield just the palm, others may shield only the dorsal surface of the hand and fingers. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of lead (Pb) or lead-equivalent material and is typically intended to be worn over patient examination or surgical gloves.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EAJ	Apron, Leaded

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53bd6220-235a-48e7-9a3f-c240f93b30b7
Public Version Date: December 23, 2022
Public Version Number: 1
DI Record Publish Date: December 15, 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: 00840348528381 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: Yes
Expiration Date: No
Manufacturing Date: Yes
Donation Identification Number: No CLOSE

Customer Contact

[?]

No Customer Contact currently defined

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