FDA.reportPublic FDA data

FLEX

Primary DI
02308501900040
Brand
FLEX
Company
MEDROBOTICS CORPORATION
Model
50073PKG
Device description
RETRACTOR BODY
Published
2018-03-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
KALRetractor, Ent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
02308501900040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
02308501900040023085019000402308501900040

GMDN Terms#

Term, Definition table
TermDefinition
Robotic surgical retractorA surgical device intended to be used in conjunction with a robotic surgical system to enable retraction of tissues during a robotic endoscopic procedure. It is designed as a long shaft with a distal retracting mechanism (e.g., fan-like opening blades), and a proximal housing intended to be connected directly to an arm of the robotic surgical system. It is not intended for surgical wound retraction or tissue cutting. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
002764627
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850190004018FLEX229952019-10-30
00850190004025FLEX246982019-10-30
00850190004032FLEX246992019-10-30
00850190004049FLEX243242018-12-07
00850190004063FLEX501522019-10-30
00850190004070FLEX231572019-10-30
00850190004087FLEX234982019-07-01
00850190004094FLEX233922019-10-30
00850190004100Flex251712019-07-01
00850190004117Flex254632019-05-07
00850190004124Flex251732019-07-01
00850190004131FLEX251782019-07-01
00850190004155Flex24324-L2019-04-30
00850190004162FLEX500832019-01-07
00850190004209FLEX500792019-01-07
00850190004247FLEX50074PKG2019-10-30
00850190004254FLEX50134PKG2019-10-30
00850190004261FLEX50137PKG2019-10-30
00850190004285FLEX50147PKG2019-10-30
00850190004292FLEX50149PKG2019-10-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776416461MillenniumAvalign Technologies, Inc.KAL2026-02-16
00757770684304Bausch + LombBausch & Lomb IncorporatedKAL2025-08-05
00757770403011Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770412280Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770419425Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770419579Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770432486Bausch + LombBausch & Lomb IncorporatedKAL2025-07-28
00757770414987Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770422050Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770423705Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770424603Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
00757770428625Bausch + LombBausch & Lomb IncorporatedKAL2025-04-11
07899798208858QuinelatoSchobell Industrial LtdaKAL2025-02-27
00810123208395Adler Instrument CompanyAdler, Inc.KAL2025-01-27
00810123208203Adler Instrument CompanyAdler, Inc.KAL2025-01-10
00757770402526Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770402762Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405343Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405718Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770405848Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770406890Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770409310Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770410620Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770413799Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770414079Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770414277Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419371Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419463Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420407Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420421Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21