AccessGUDID - DEVICE: Croma (05060359560223)

GUDID

Device Identifier (DI) Information

Brand Name: Croma
Version or Model: Slypseal Flex
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7-HS1-001
Company Name: CREO MEDICAL LIMITED

Primary DI Number: 05060359560223
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 733853373 *Terms of Use

Device Description: HS1 is indicated for use in endoscopic injection therapy (to deliver pharmacological injection agents, such as vasoconstrictors) and endoscopic electrohemostasis (cauterization of tissue and coagulation of blood) of actual or potential bleeding sites in the gastrointestinal tract. These sites will include the following • Peptic Ulcers • Dieulafoy Lesions • Mallory-Weiss Tears • Bleeding Polyp Stalks • Arteriovenous Malformations (AVMs) • Angiomata The HS1 also has irrigation capability. Any other use is not recommended.

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?
64631	Endoscopic microwave ablation probe/needle	A flexible, invasive, hand-held endoscopic device assembly intended to deliver microwave energy to tissues for coagulation, whilst allowing injection of a solution (e.g., vasoconstrictive agents) primarily to help control/stop serious bleeds (haemostasis) during endoscopic surgery. It includes a microwave antenna, a port with a distal needle, and proximal handpiece with controls for needle retraction. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Handling Environment Temperature: between 10 and 30 Degrees Celsius
Handling Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 69 and 106 KiloPascal
Storage Environment Atmospheric Pressure: between 69 and 106 KiloPascal
Storage Environment Humidity: between 20 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Length: 1.8 Meter
Outer Diameter: 3.2 Millimeter

Device Record Status

Public Device Record Key: 87bddad4-ddb2-42fa-a4d7-78d2129c17d1
Public Version Date: November 09, 2023
Public Version Number: 3
DI Record Publish Date: December 31, 2020