AccessGUDID - DEVICE: SURGIPLUS (00683534060520)

GUDID

Device Identifier (DI) Information

Brand Name: SURGIPLUS
Version or Model: 1
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 68-6201-B
Company Name: A PLUS INTERNATIONAL INC.

Primary DI Number: 00683534060520
Issuing Agency: GS1
Commercial Distribution End Date: November 21, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 191705904 *Terms of Use

Device Description: PE FILM GOWN A garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

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):	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?
35492	Isolation gown, single-use	A garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OEA	Non-Surgical Isolation Gown

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: 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: 912db0a2-16a5-4d61-bfd9-bf8c6276893a
Public Version Date: November 21, 2022
Public Version Number: 4
DI Record Publish Date: July 02, 2020

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
70683534060529	15	00683534060520	2022-11-21	Not in Commercial Distribution	dispenser
80683534060526	5	70683534060529	2022-11-21	Not in Commercial Distribution	case