AccessGUDID - DEVICE: Fenestrated Surgical Drape (00634916349504)

GUDID

Device Identifier (DI) Information

Brand Name: Fenestrated Surgical Drape
Version or Model: 96896920
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 96896920
Company Name: STANDARD TEXTILE CO., INC.

Primary DI Number: 00634916349504
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 144
Labeler D-U-N-S® Number*: 006999858 *Terms of Use

Device Description: Heart Drape, 30 x 34, 1-Ply, Perval Bleach, 10 3/4 x 6 1/2 Rectangular Fenestration, Binding Around Fenestration, Hemmed on All Side

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:	No
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?
47780	Patient surgical drape, reusable	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). This is a reusable device intended to be sterilized prior to use.	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 [?]
Moist Heat or Steam Sterilization

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: 8b81238a-fb9c-4540-8e0e-88e7e6ebd949
Public Version Date: July 27, 2023
Public Version Number: 3
DI Record Publish Date: January 29, 2018