AccessGUDID - DEVICE: MEDLINE (10080196469451)

GUDID

Device Identifier (DI) Information

Brand Name: MEDLINE
Version or Model: DYND73032
Commercial Distribution Status: In Commercial Distribution
Catalog Number: DYND73032
Company Name: MEDLINE INDUSTRIES, INC.

Primary DI Number: 10080196469451
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 025460908 *Terms of Use

Device Description: STERILE COTTON BALLS LARGE 5/P

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":	Yes
For Single-Use:	Yes
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?
63282	Cotton wool ball, sterile	A sterile, non-dedicated device designed as an absorbent, spherical mass of cotton or man-made fibres intended for use to absorb fluids, typically in a surgical setting. It may be radiopaque to make it visible on x-ray, and may have an attached cord to improve traceability in a surgical setting. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
FRL	FIBER, MEDICAL, ABSORBENT

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: f936dbd9-6a41-4ec6-9603-778d030a1c4c
Public Version Date: January 10, 2022
Public Version Number: 1
DI Record Publish Date: January 01, 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
40080196469452	25	10080196469451		In Commercial Distribution	CASE

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

Customer Contact

[?]

Phone: +1(800)633-5463
Email: CUSTOMERSERVICE@MEDLINE.COM

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