FDA.reportPublic FDA data

SlypSeal Flex

Primary DI
05060359560223
Brand
SlypSeal Flex
Company
CREO MEDICAL LIMITED
Model
7-HS1-001
Catalog number
7-HS1-001
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)• AngiomataThe HS1 also has irrigation capability. Any other use is not recommended.
Published
2020-12-31
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060359560216PackageGS15In Commercial Distribution
05060359560223PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060359560216050603595602165060359560216
05060359560223050603595602235060359560223

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic microwave ablation probe/needleA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length1.8Meter
Outer Diameter3.2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure69 KiloPascal106 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature10 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure69 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+441291637300customerservice@creomedical.com
+18662261170uscustomerservice@creomedical.com

Regulatory Flags#

DUNS number
733853373
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060359560100Footswitch7-PG1-1327-PG1-1322026-04-17
05060359560209MicroBlate Flex7-AB1-0012021-07-29
05060359560513Croma Generator7-EMR-050 V6.017-EMR-0502024-01-09
05060359560575Speedboat RS2 8 Fr Instrument7-RS2-0037-RS2-0032023-11-08
05060359560643Speedboat Ultraslim LongPRD-SB1-001PRD-SB1-0012023-12-06
05060359561183CROMA Electrosurgical Generator7-EMR-050 V6.0017-EMR-0502024-10-08
05060359560292CROMA Electrosurgical Generator7-EMR-050 V4.02021-03-15
05060359560070Interface Cable, single use, 1.5 m2-RS2-2102-RS2-2102020-11-23
05060359560025Speedboat Inject 10 Fr7-RS2-0017-RS2-0012018-11-14
05060359560063Procedure Pack Interface Cable, single use, 1.5 m7-RS2-210 7-RS2-2102018-11-15
05060359560087CROMA Electrosurgical Generator with Footswitch7-EMR-050 2018-11-15
05060359560124CROMA Electrosurgical Generator7-EMR-050 V3.07-EMR-0502019-03-20
05060359560674Speedboat UltraSlim ShortPRD-SB1-002PRD-SB1-0022025-10-03
05060359561329Speedboat Notch ShortPRD-SB1-004PRD-SB1-0042025-10-03
05060359560438SpydrBlade FlexPRD-RG1-001PRD-RG1-0012025-06-12
05060359560971MicroBlate Fine7-NP1-1007-NP1-1002025-05-05
05060359560490MicroBlate Fine7-NP1-1007-NP1-1002025-05-05
05060359561077Speedboat Notch LongPRD-SB1-003PRD-SB1-0032025-03-26
05060359561206CROMA Electrosurgical GeneratorPRD-EMR-050PRD-EMR-0502025-02-10
05060359561213CROMA Electrosurgical GeneratorPRD-EMR-050PRD-EMR-0502025-02-10

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