FDA.reportPublic FDA data

GT Metabolic Magnetic Retrieval Device (MRD)

Primary DI
00850054216106
Brand
GT Metabolic Magnetic Retrieval Device (MRD)
Company
Gt Metabolic Solutions, Inc.
Model
MRD-02
Published
2025-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
PTQEndoscopic Magnetic Retriever, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PTQEndoscopic Magnetic Retriever, ExemptGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850054216106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850054216106008500542161068500542161060850054216106

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal/airway foreign body retrieval basket, single-useA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108055496
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850054216113GT Metabolic DI Magnet - 50mmMAG-022025-03-14
00850054216007GT Metabolic Laparoscopic Positioning DevicePD-272024-12-13
00850054216014GT Metabolic Laparoscopic Positioning DevicePD-242024-12-13
00850054216021GT Metabolic Laparoscopic Positioning DevicePD-212024-12-13
00850054216038GT Metabolic Laparoscopic Positioning DevicePD-182024-12-13
00850054216045GT Metabolic Laparoscopic Positioning DevicePD-122024-12-13
00850054216052GT Metabolic Delivery SystemDS-012024-12-13
00850054216069GT Metabolic DI Magnet - 40mmMAG-012024-12-13
00850054216144GT Metabolic Instrument SetIS-012024-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850024506015Melzi Sharps Finder ShortMelzi CorporationPTQ2022-07-25
10850024506012Melzi Sharps Finder ShortMelzi CorporationPTQ2022-07-25
00850024506008Melzi Sharps FinderMelzi CorporationPTQ2021-01-14
10850024506005Melzi Sharps FinderMelzi CorporationPTQ2021-01-14