FLEX

GUDID 04808501900043

FENESTRATED GRASPER

MEDROBOTICS CORPORATION

Laparoscopic blunt dissector

• Primary Device ID: 04808501900043
• NIH Device Record Key: e2572602-146e-4685-a43d-0fad46373f82
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FLEX
• Version Model Number: 50418
• Company DUNS: 002764627
• Company Name: MEDROBOTICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850190004483 [Primary]
GS1	04808501900043 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140662

FDA Product Code

• GCJ: Laparoscope, General & Plastic Surgery

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2020-02-26
• Device Publish Date: 2019-01-07

On-Brand Devices [FLEX]

• 00508501900046: FLEX CAMERA
• 00408501900049: Flex TO Drive
• 00308501900042: FLEX CONSOLE
• 00208501900045: FLEX CART
• 00608501900043: FLEX RETRACTOR SYSTEM
• 00708501900040: FLEX STAND
• 00808501900047: Flex TO Instrument Support & Assembly
• 00108501900048: FLEX BASE
• 08208501900047: Obturator, 4.5cm
• 07208501900048: Bipolar Maryland Dissector
• 06808501900041: Micro Flex Laser Holder 1100
• 06708501900044: Needle Driver
• 00850190004667: Micro Flex Triangle Forceps
• 06508501900040: Micro Flex Alligator Grasper
• 06408501900043: Micro Flex Sickle Knife
• 06308501900046: Micro Flex Scissors
• 05608501900048: Flex Case Kit - Option 12
• 05508501900041: Flex Case Kit - Option 11
• 05308501900047: Flex Case Kit - Option 9
• 05008501900046: MONOPOLAR SPATULA
• 04908501900040: MONOPOLAR NEEDLE KNIFE
• 04808501900043: FENESTRATED GRASPER
• 04708501900046: MONOPOLAR MARYLAND DISSECTOR
• 02008501900049: FLEX MONOPOLAR SCISSORS
• 01608501900042: FLEX LASER HOLDER
• 07608501900046: TO-LX Case Kit Option 3
• 07508501900049: TO-LX Case Kit Option 2
• 07408501900042: TO-LX Case Kit Option 1
• 07308501900045: Monopolar L-Hook
• 07108501900041: Flex TA Instrument Support & Assembly
• 07008501900044: Hypercurved Laryngeal Blade, 92-125mm x 36mm Wide
• 06908501900048: Hypercurved Laryngeal Blade, 120-150mm x 36mm Wide
• 06608501900047: Micro Flex Triangle Forceps
• 06208501900049: FLEX CASE KIT - OPTION 6
• 06108501900042: FLEX CASE KIT - OPTION 5
• 06008501900045: FLEX CASE KIT - OPTION 4
• 05908501900049: FLEX CASE KIT - OPTION 3
• 05808501900042: FLEX CASE KIT - OPTION 2
• 05708501900045: FLEX CASE KIT - OPTION 1
• 05408501900044: Flex Case Kit- Option 10
• 05208501900040: Flex Case Kit- Option 8
• 05108501900043: Flex Case Kit- Option 7
• 04608501900049: RETRACTOR BODY
• 04508501900042: TONGUE BLADE, TEXTURED, 80-110MM X 32MM WIDE
• 04408501900045: TONGUE BLADE, TEXTURED, 50-80MM X 32MM WIDE
• 04308501900048: RETRACTOR SYSTEM TONGUE-MANDIBLE BLADE, TEXTURED, 50-80MM X 32MM WIDE
• 04208501900041: FLEX CURVED LARYNGEAL BLADE, 130-160mm X 36mm Proximal X 16mm Distal
• 04108501900044: CURVED LARYNGEAL BLADE, 85-115mm X 36mm Proximal X 23mm Distal
• 08608501900045: TA Case Kit 4
• 08508501900048: TA Case Kit 3