FDA UDI
In Commercial Distribution
🇺🇸 United States
Croma
DI: 05060359560223
·
Model: Slypseal Flex
·
CREO MEDICAL LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Croma
- Primary DI
- 05060359560223
- Version / Model
- Slypseal Flex
- Catalog Number
- 7-HS1-001
- Company Name
- CREO MEDICAL LIMITED
- Labeler DUNS
- 733853373
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-12-31
- Public Version
- 3
- Public Version Date
- 2023-11-09
- Public Version Status
- Update
- Public Device Record Key
- 87bddad4-ddb2-42fa-a4d7-78d2129c17d1
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
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| KNS | Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | Gastroenterology, Urology | 876.4300 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 05060359560223 | GS1 | ||||
| Package | 05060359560216 | GS1 | Carton | 5 | In Commercial Distribution |
Customer Contacts
- Phone
- +18662261170
- [email protected]
- Phone
- +441291637300
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 1.8 | Meter | |
| Outer Diameter | 3.2 | Millimeter |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 69 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 69 – 106 KiloPascal
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- 10 – 30 Degrees Celsius