AccessGUDID - DEVICE: CARDINAL HEALTH (50885380164390)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 29350ANC
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 29350ANC
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380164390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 660
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Three Quarter Sheet-Reinforced, Nonsterile, 56 x 77 in. (142 x195cm), with absorbent reinforcement, 25 x 42 in. (63 x 106cm)

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):	No
Over the Counter (OTC):	Yes
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?
47783	Patient surgical drape, single-use	A noninvasive sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to function as a barrier to cross contamination (e.g., isolate a site of surgical incision, protect non-operative anatomy). It is not designed with specific heat-reflective or laser resistant materials. It is available in a variety of designs (e.g., flat sheet with or without an access hole, leg tube or an adhesive film sheet otherwise known as an incise drape). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, surgical, exempt

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: a63918a8-3142-4b74-bbdd-07ad0d4f0a89
Public Version Date: November 29, 2024
Public Version Number: 2
DI Record Publish Date: November 28, 2018