FDA.report

M-Flex®

Primary DI
00816734020258
Brand
M-Flex®
Company
DIVERSATEK HEALTHCARE, INC.
Model
1207-24
Catalog number
1207-24
Device description
Blue Silicone Tungsten Hurst Esophageal Dilator, 24 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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology

Product Code Classifications

CodeDeviceSpecialtyClass
FATBougie, Esophageal, And Gastrointestinal, Gastro-UrologyGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816734020258PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816734020258008167340202588167340202580816734020258

GMDN Terms

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

TypeValueUnit
Catheter Gauge24French

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Store flat, do not hang

Sterilization Methods

Method
High-level Disinfectant;Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags

DUNS number
030650113
Device count
1
DM exempt
false
Premarket exempt
false
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
false
Sterilization required before use
true

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00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16
00816734023457Diversatek HealthcareHRIMSD-KITHRIMSD-KIT2025-05-16
00816734023464Diversatek HealthcareHRAM-KITHRAM-KIT2025-05-16
00816734023471Diversatek HealthcareEMG-KITEMG-KIT2025-05-16
00816734023488Diversatek HealthcareCOMP-KITCOMP-KIT2025-05-16
00816734023426Zvu®ZVU-3 Revision 3.4.0ZVU-32025-03-26
10816734023416BullDog®1203-931203-932024-11-22
M78312011101Diversatek Healthcare1201-1101201-1102024-10-31
10816734023362EZ-Ject1186-011186-012024-07-18
10816734023379EZ-Ject1186-021186-022024-07-18
10816734023386EZ-Ject1186-031186-032024-07-18
10816734023393EZ-Ject1186-041186-042024-07-18
M78312011081Diversatek Healthcare1201-1081201-1082024-06-07
M78312011061Diversatek Healthcare1201-1061201-1062024-01-31
10816734023355BullDog®1203-611203-612023-08-25
00816734023181SafeGuide® Single1215-151215-152023-08-14

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Primary DIBrandCompanyProduct codePublished
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24026704719628PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
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24026704719710PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719727PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719734PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719741PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
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24026704719765PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
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24026704719789PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719796PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719802PILLINGTELEFLEX INCORPORATEDFAT2021-03-11
24026704719819PILLINGTELEFLEX INCORPORATEDFAT2021-03-11