AccessGUDID - DEVICE: XSTAT (00851587006059)

GUDID

Device Identifier (DI) Information

Brand Name: XSTAT
Version or Model: XSTAT 30
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: FIN-0001-03
Company Name: REVMEDX, INC.

Primary DI Number: 00851587006059
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 961523441 *Terms of Use

Device Description: A hemostatic device for severe bleeding. Each device comprises approximately 92 small hemostatic sponges individually marked with an X-shaped radiopaque marker.

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?
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
PGZ	Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K152624	000

Device Exempt from Premarket Submission: No 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
Special Storage Condition, Specify: Store device in room temperature

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 30 Millimeter

Device Record Status

Public Device Record Key: b3ad1c65-4320-4ef6-9b09-bff965961e58
Public Version Date: August 24, 2021
Public Version Number: 5
DI Record Publish Date: September 02, 2016