FDA.report

Mediflex Universal Round Bar Table Mounted Retractor Systems

Primary DI
00842102109331
Brand
Mediflex Universal Round Bar Table Mounted Retractor Systems
Company
FLEXBAR MACHINE CORPORATION
Model
72107-R
Device description
Univ. TMR Blade, Kelly 1 x 3" (2.5 x 7.6cm)
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
FFORetractor, Self-Retaining

Product Code Classifications

CodeDeviceSpecialtyClass
FFORetractor, Self-RetainingGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842102109331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102109331008421021093318421021093310842102109331

GMDN Terms

TermDefinition
Gastric contractility modulation system pulse generatorA hermetically-sealed, battery-powered device implanted beneath the skin and connected to implanted leads to monitor intrinsic electrical and mechanical gastric activity and deliver gastric contractility modulation (GCM) electrical signals to the stomach to help improve glycaemic control and induce weight loss typically in an obese patient with type 2 diabetes mellitus. The device is programmed by and transmits gastric diagnostic data to an external programmer telemetrically.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
047644935
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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