FDA.report

M-Flex®

Primary DI
00816734020074
Brand
M-Flex®
Company
DIVERSATEK HEALTHCARE, INC.
Model
1206-34
Catalog number
1206-34
Device description
Blue Silicone Tungsten Maloney Esophageal Dilator, 34 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
00816734020074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816734020074008167340200748167340200740816734020074

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 Gauge34French

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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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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