FDA.reportPublic FDA data

Mediflex Laparoscopic Instruments - Suture Grasper Guides

Primary DI
00842102112348
Brand
Mediflex Laparoscopic Instruments - Suture Grasper Guides
Company
FLEXBAR MACHINE CORPORATION
Model
94420
Device description
Suture Passer Guide 10mm x 9.3cm
Published
2019-01-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842102112348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102112348008421021123488421021123480842102112348

GMDN Terms#

Term, Definition table
TermDefinition
Suturing guideA surgical device that is placed over an open wound to the aid the surgeon in placing the sutures so that, when pulled tight, the sutures will meet. It is typically made of metal or plastic material. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
047644935
Device count
1
Premarket exempt
true
Manufacturing date on label
true
Sterilization required before use
true

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