FDA.reportPublic FDA data

M-Catch

Primary DI
10816734021382
Brand
M-Catch
Company
DIVERSATEK HEALTHCARE, INC.
Model
1175-10
Catalog number
1175-10
Device description
Polyp Retrieval Net, 3x6cm, 230cm
Published
2018-08-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FGXSnare, Non-Electrical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGXSnare, Non-ElectricalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10816734021382PackageGS15In Commercial Distribution
00816734021385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081673402138210816734021382
00816734021385008167340213858167340213850816734021385

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/airway foreign body retrieval basketA flexible device intended to access the gastrointestinal (GI) tract, and/or the airway tree, via the working channel of an appropriate endoscope to atraumatically remove foreign bodies during an endoscopic procedure; it may in addition be intended for removal of severed polyps and tissue samples (biopsy). It is typically designed with a long, thin, flexible body that has an expandable basket at the distal end in which objects are caught for extraction. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth6Centimeter
Length230Centimeter
Width3Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags#

DUNS number
030650113
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816734021286InnerVision®1465-401465-402018-09-18
00816734021293InnerVision®1465-501465-502018-09-18
00816734021217InnerVision®1450-021450-022018-09-18
00816734021224InnerVision®1450-401450-402018-09-18
00816734021231InnerVision®1450-501450-502018-09-18
00816734021248InnerVision®1450-561450-562018-09-18
00816734021255InnerVision®1455-401455-402018-09-18
00816734021262InnerVision®1455-501455-502018-09-18
00816734021279InnerVision®1455-561455-562018-09-18
00816734021309InnerVision®1465-561465-562018-09-18
00816734023518BullDog®1203-401203-402025-12-05
10816734023515BullDog®1203-401203-402025-12-05
M78312011160Diversatek Healthcare1201-1161201-1162025-11-14
00816734021682Diversatek HealthcareA86-1070A86-10702023-06-30
00816734021835Diversatek HealthcareA86-4300-10A86-4300-102023-06-30
00816734021859Diversatek HealthcareA86-5070A86-50702023-06-30
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809909421457SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421464SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421471SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
08809909421488SnareTAEWOONGMEDICAL.CO.,LTDFGX2026-04-27
46932503554518EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
46932503554525EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
56932503554515EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
56932503554522EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-12-06
00724995243753Exacto MundoUS EndoscopyFGX2025-08-19
00724995243760Exacto MundoUS EndoscopyFGX2025-08-19
10724995243750Exacto MundoUS EndoscopyFGX2025-08-19
10724995243767Exacto MundoUS EndoscopyFGX2025-08-19
06932503554510EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
06932503554527EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
16932503554517EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
16932503554524EnTrap(TM) Polyp Retrieval Snare NetMicro-Tech (Nanjing) Co., Ltd.FGX2025-04-24
00724995243746Exacto MundoUS EndoscopyFGX2025-01-31
10724995243743Exacto MundoUS EndoscopyFGX2025-01-31
06936603226971Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603226988Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603227015Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06936603227022Disposable Polypectomy Cold SnareYangzhou Fartley Medical Instrument Technology Co., LtdFGX2025-01-21
06941513202243Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202250Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202274Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
06941513202281Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202240Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202257Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202271Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07
16941513202288Disposable Cold SnaresJiangsu Vedkang Medical Science and Technology Co.,Ltd.FGX2025-01-07