FDA.reportPublic FDA data

N/A

Primary DI
20705036003974
Brand
N/A
Company
Obtech Medical Sàrl
Model
RGCT180
Catalog number
RGCT180
Device description
Gastric Calibration Tube
Published
2016-07-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNTTUBES, GASTROINTESTINAL (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30705036003971PackageGS142Not in Commercial Distribution
20705036003974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
3070503600397130705036003971
2070503600397420705036003974

GMDN Terms#

Term, Definition table
TermDefinition
Gastric calibration tubeA thin, flexible, hollow cylinder with an inflatable balloon at the distal end designed to be inserted into a patient's stomach through the mouth and oesophagus to create and size a gastric pouch typically for a bariatric gastric surgical procedure (e.g., sleeve gastrectomy, gastric banding). The proximal end may include a check valve and connects to a syringe, typically included, intended to inflate the balloon to a predetermined volume; fluid suction/irrigation ports are provided at the distal end. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266customersupport@eesus.jnj.com

Regulatory Flags#

DUNS number
486911852
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20705036003981N/ARGCT360RGCT3602016-07-15
20705036011788N/ARHUB50RHUB502016-07-15
20705036011795N/ARHUB90RHUB902016-07-15
20705036003967N/ARGBRS1RGBRS12016-07-15
20705036004018NARLZPT2RLZPT22014-09-17
30705036003964N/ARGBRS1RGBRS12016-07-15
30705036003971N/ARGCT180RGCT1802016-07-15
30705036003988N/ARGCT360RGCT3602016-07-15
30705036004015NARLZPT2RLZPT22014-09-17
20705036004001NARLZB32RLZB322014-09-17
30705036004008NARLZB32RLZB322014-09-17
20705036011665NARLZB22TRLZB22T2014-09-17
20705036011672NARLZB32D1RLZB32D12014-09-17
20705036011689NARLZB32DG1RLZB32DG12014-09-17
20705036011696NARLZB32DGTRLZB32DGT2014-09-17
20705036011702NARLZB32DTRLZB32DT2014-09-17
30705036011785N/ARHUB50RHUB502016-07-15
30705036011792N/ARHUB90RHUB902016-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00350770997841MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997858MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997896MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 14 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997902MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997919MIC* Percutaneous Endoscopic Gastrostomy (PEG) KIT, 24 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997964MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
00350770997971MIC* Percutaneous Endoscopic Gastrostomy (PEG) Kit, 20 Fr, PULLAvanos Medical, Inc.KNT2026-10-20
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