AccessGUDID - DEVICE: Situate (10884521706897)

GUDID

Device Identifier (DI) Information

Brand Name: Situate
Version or Model: L1818-04P01CN-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Covidien LP

Primary DI Number: 10884521706897
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 180
Labeler D-U-N-S® Number*: 058614483 *Terms of Use

Device Description: Laparotomy Sponge-RF and X-ray Detectable. Caution: For Manufacturing, Processing or Repacking.

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
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
Handling Environment Atmospheric Pressure: between .5 and 1.06 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between .7 and 1.06 KiloPascal
Handling Environment Temperature: between -22 and 140 Degrees Fahrenheit
Storage Environment Temperature: between 50 and 104 Degrees Fahrenheit
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Width: 18 Inch
Length: 18 Inch

Device Record Status

Public Device Record Key: 38d2672d-690a-45c9-b031-8f9b19fe1e4c
Public Version Date: June 13, 2025
Public Version Number: 7
DI Record Publish Date: September 26, 2018