AccessGUDID - DEVICE: ORLocate (15060356150158)

GUDID

Device Identifier (DI) Information

Brand Name: ORLocate
Version or Model: ORLocate Vaginal Packing
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: VAG4X36LPFLNS
Company Name: Steris Corporation

Primary DI Number: 15060356150158
Issuing Agency: GS1
Commercial Distribution End Date: March 13, 2023
Device Count: 240
Labeler D-U-N-S® Number*: 177360039 *Terms of Use

Device Description: ORLocate RFID Vaginal Packing Loop and Fold is used with the ORLocate Sponge Solution System.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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):	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?
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / sponge,nonresorbable for external use
GDY	Gauze/sponge, internal, x-ray detectable

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
Length: 36 Inch
Width: 4 Inch

Device Record Status

Public Device Record Key: ece47ac6-bc1d-4794-acca-27207ffd5c34
Public Version Date: March 14, 2023
Public Version Number: 2
DI Record Publish Date: October 31, 2022