FDA.reportPublic FDA data

FLEX

Primary DI
02008501900049
Brand
FLEX
Company
MEDROBOTICS CORPORATION
Model
50079
Device description
FLEX MONOPOLAR SCISSORS
Published
2019-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140662000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140662000FLEX ENDOSCOPIC INSTRUMENTSDesign Standards Corp.2014-06-11GCJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
02008501900049PreviousGS10
00850190004209PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
02008501900049020085019000492008501900049
00850190004209008501900042098501900042090850190004209

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic blunt dissectorA sterile, rigid, manual instrument designed to facilitate blunt dissection between tissue planes during laparoscopic procedures, and may additionally be used during open surgical interventions of the abdomen. It is typically made of high-grade stainless steel and plastic materials, and usually consists of a long, thin shaft with a handle and activation lever proximally, and distally a steerable, flexible blunt tip used to mechanically disrupt tissues. Using the lever, the operator can articulate and lock the tip at an angle. It may also be used to snare and pull a pre-tied suture or interface with other similarly shaped articles (e.g., gastric band tubing). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002764627
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850190004193Flex253862019-07-01
00850190004018FLEX229952019-10-30
00850190004025FLEX246982019-10-30
00850190004032FLEX246992019-10-30
00850190004070FLEX231572019-10-30
00850190004087FLEX234982019-07-01
00850190004100Flex251712019-07-01
00850190004124Flex251732019-07-01
00850190004131FLEX251782019-07-01
00850190004513FLEX253272019-04-01
00850190004520FLEX253282019-04-01
00850190004537FLEX253292018-12-07
00850190004544FLEX253302019-04-01
00850190004551FLEX253312018-12-07
00850190004568FLEX253322018-12-07
00850190004711FLEX255972019-04-30
00850190004742Flex257762019-04-01
00850190004759Flex257772019-04-01
00850190004766Flex257782019-04-01
00850190004827FLEX261142018-12-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091414ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091421ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091438ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-05
00198506091247ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00198506091254ELMED INCORPORATEDELMED INCORPORATEDGCJ2026-06-03
00192896123427TrocarSONTEC INSTRUMENTS, INC.GCJ2026-06-02
00192896123434Flexible Trocar SleeveSONTEC INSTRUMENTS, INC.GCJ2026-06-02
E496C35BTU200C35-Bipolar Tube L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBDM200C35- Bipolar Maryland Insert L20cm D 3,5mmAB MEDICAGCJ2026-05-28
E496C35IBFS200C35-Bipolar Insert L 20cm D 3,5mmAB MEDICAGCJ2026-05-28
08800112400352cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400482cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800112400499cCeLLVPIX Medical, Inc.GCJ2026-05-14
08800042701833ARTISENTIAL TROCARLIVSMEDGCJ2026-04-17
G4532420530BC0PEAK MEDICALPeak Medical Distribution Inc.GCJ2026-02-24
10192253052398DevonCardinal Health 200, LLCGCJ2025-05-29
08904332600766MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2025-05-19
10192253052442DevonCardinal Health 200, LLCGCJ2025-03-27
10080196800612MedlineMEDLINE INDUSTRIES, INC.GCJ2024-03-05
07613327413281Connected OR HubSTRYKER CORPORATIONGCJ2023-07-26
07613327562545NASTRYKER CORPORATIONGCJ2021-12-23
07613327562552NASTRYKER CORPORATIONGCJ2021-12-23
08051414960468Cyber BladeSIDAM SRLGCJ2021-02-04
07613327502800PinpointSTRYKER CORPORATIONGCJ2019-07-30
076133273823891688STRYKER CORPORATIONGCJ2019-01-17
07613327419146Connected OR HUBSTRYKER CORPORATIONGCJ2018-12-19
07613327419153Connected OR HUBSTRYKER CORPORATIONGCJ2018-12-19
08806182216626LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182216657LapbagSejong Medical Co., LtdGCJ2018-04-06
08806182210334LaportSejong Medical Co., LtdGCJ2018-04-05