Deluxe Laparoscopic Instruments

GUDID 00842102114670

Deluxe Peritoneal Scissor, Serrated Blades, 5mm x 36cm, Insert Only

FLEXBAR MACHINE CORPORATION

Endoscopic electrosurgical handpiece/electrode, monopolar, reusable
Primary Device ID00842102114670
NIH Device Record Key0b05cbf8-a280-4de6-9c14-c8db0d8f92be
Commercial Distribution StatusIn Commercial Distribution
Brand NameDeluxe Laparoscopic Instruments
Version Model Number91661-D-I
Company DUNS047644935
Company NameFLEXBAR MACHINE CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100842102114670 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GCJLaparoscope, General & Plastic Surgery

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


[00842102114670]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-10-04
Device Publish Date2021-09-24

Devices Manufactured by FLEXBAR MACHINE CORPORATION

00842102116315 - Holders and Positioners - Nathanson Hooks2025-08-05 Special old style med 6.3mm Nathanson Retractor with Hex Fitting
00842102116254 - Mini-Bookler Table Mounted Retractor Systems2025-07-21 ENTrac Blade, Tongue, Curved Small, In-Line
00842102116261 - Mini-Bookler Table Mounted Retractor Systems2025-07-21 ENTrac Blade, Tongue, Left, In-Line
00842102116278 - Mini-Bookler Table Mounted Retractor Systems2025-07-21 ENTrac Blade, Tongue, Right, In-Line
00842102116285 - Mini-Bookler Table Mounted Retractor Systems2025-07-21 ENTrac Blade, Tongue, Curved Large, In-Line
00842102116292 - Mini-Bookler Table Mounted Retractor Systems2025-07-21 ENTrac Blade, Laryngeal, Curved 17cm, In-Line
00842102116308 - Mini-Bookler Table Mounted Retractor Systems2025-07-21 ENTrac Blade, Tongue, Curved Medium, In-Line
00842102116247 - StrongArm Surgical Holders and Positioners2025-05-13 StrongArm, Single w/Short Distal Arm, QC Fitting, Long Post (no Rail clamp)

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.