AccessGUDID - DEVICE: FlexGard (00860010353226)

GUDID

Device Identifier (DI) Information

Brand Name: FlexGard
Version or Model: CRG-SL-MTF
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CRG-SL-MTF
Company Name: LDI Solutions, LLC

Primary DI Number: 00860010353226
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 175311088 *Terms of Use

Device Description: Cut resistant glove liners, sterile, size large. (Packaged 10 pair/box. Invoiced by pair.)

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:	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?
18039	Glove liner	A cloth glove intended to be worn as a liner underneath rubber, plastic, or latex gloves (examination or surgical) to minimize the risk of allergic reactions, rashes, and other skin irritations, or to reduce the risk of sharps injuries. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGO	Surgeon'S Gloves

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K190782	000

Device Exempt from Premarket Submission: No 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: 8ebce1c9-abe9-4766-b9ab-691bf4abc74a
Public Version Date: April 19, 2024
Public Version Number: 1
DI Record Publish Date: April 11, 2024