FDA.reportPublic FDA data

RETRACTOR

Primary DI
B974ER9040S0
Brand
RETRACTOR
Company
DR.FRIGZ INTERNATIONAL(PVT)LTD,
Model
EASTMAN RETRACTOR
Catalog number
ER9040S
Device description
EASTMAN RETRACTOR 90 MM X 40 MM
Published
2022-11-21
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
true

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B974ER9040S0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, single-useA hand-held, non-self-retaining surgical instrument intended to be used to separate/draw aside the margins of a wound/incision to allow access to tissues/organs during open surgery; it is not dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Regulatory Flags#

DUNS number
645680125
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B974111310SCISSORSTENOTOMY SCISSORS111312022-11-22
B974111400Single Use ScissorEPISIOTOMY SCISSORS111402022-11-22
B974122000FORCEPSPEAN FORCEPS122002022-11-22
B974132420FORCEPSLORNA TOWEL FORCEPS132422022-11-22
B974132430FORCEPSLORNA TOWEL FORCEPS132432022-11-22
B9741629004NEEDLE HOLDERMAYO HEGAR NEEDLE HOLDERS162902022-11-22
B9742370FORCEPSSPONGE FORCEPS2372022-11-22
B974256950EAR FORCEPSJANSEN EAR FORCEPS256952022-11-22
B9743290808NAIL NIPPERSNAIL NIPPERS 329082022-11-22
B97450524507FORCEPSDebakey Forceps5052452022-11-22
B9748112604OPERATING SCISSORSCVD 811262022-11-22
B974813100SCISSORSMAYO SCISSORS813102022-11-22
B9748148007SCISSORSSTRABISMUS SCISSORS814802022-11-22
B974814850SCISSORS STRABISMUS SCISSORS 814852022-11-22
B974818900FORCEPSPEAN FORCEPS818902022-11-22
B974AF25720S0EAR FORCEPSMICRO ALLIGATOR FORCEPSAF25720S2022-11-22
B974ATF8PAS0FORCEPSALLIS TISSUE FORCEPSATF8PAS2022-11-22
B974BES6PAS0SCISSORSEPISIOTOMY SCISSORSBES6PAS2022-11-22
B974BNH21906NEEDLE HOLDERBAUMGARTNER NEEDLE HOLDERBNH2192022-11-22
B974BTC17306TOWEL CLAMPTOWEL CLAMPBTC1732022-11-22

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Primary DI, Brand, Company table
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