FDA.report

Mediflex Laparoscopic Instruments - Suture Grasper Guides

Primary DI
00842102112331
Brand
Mediflex Laparoscopic Instruments - Suture Grasper Guides
Company
FLEXBAR MACHINE CORPORATION
Model
94415
Device description
Suture Passer Guide, 10mm x 11.2cm
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
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842102112331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842102112331008421021123318421021123310842102112331

GMDN Terms

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
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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