FDA.reportPublic FDA data

M-Flex®

Primary DI
00816734020371
Brand
M-Flex®
Company
DIVERSATEK HEALTHCARE, INC.
Model
1207-48
Catalog number
1207-48
Device description
Blue Silicone Tungsten Hurst Esophageal Dilator, 48 French
Published
2016-09-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816734020371PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816734020371008167340203718167340203710816734020371

GMDN Terms#

Term, Definition table
TermDefinition
Oesophageal bougie, reusableA cylindrical, rod-like, surgical instrument that is used to explore and/or dilate a stricture during oesophagoscopic or bronchoscopic procedures. It may be designed with a semi-rigid tapered end (Maloney type) or with a blunt end (Hurst type), and may be hollow for the passing of other slender devices through it. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge48French

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store flat, do not hang

Sterilization Methods#

Method table
Method
"[""High-level Disinfectant"", ""Moist Heat or Steam Sterilization""]"
High-level Disinfectant;Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
030650113
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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
G461EGCT36M0EndolumikEndolumik, Inc.FAT2024-08-06
G461EGCT40M0EndolumikEndolumik, Inc.FAT2024-08-06
G461EGCT360EndolumikEndolumik, Inc.FAT2023-05-15
G461EGCT400EndolumikEndolumik, Inc.FAT2023-05-15
14026704719539PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719546PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719553PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719560PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719577PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719584PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719591PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719607PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719614PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719621PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719638PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719645PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719652PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719669PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719676PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719683PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719690PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719706PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719713PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719720PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719737PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719744PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719751PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719768PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719775PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
14026704719782PILLINGTELEFLEX INCORPORATEDFAT2021-03-11