FDA.report

Reddick-Saye Screw Retractor

Primary DI
00840663101979
Brand
Reddick-Saye Screw Retractor
Company
LEMAITRE VASCULAR, INC.
Model
e2504-01
Catalog number
e2504-01
Device description
Reddick-Saye Screw Retractor Kit, 4 pack, eIFU
Published
2015-06-30
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

Related Records

Contact Domains

Product Codes

CodeName
GADRetractor

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840663101979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663101979008406631019798406631019790840663101979

GMDN Terms

TermDefinition
Abdominal retractor, hand-heldA surgical instrument designed to be held by the surgeon or assistant to separate the margins of an abdominal incision, typically during deep surgery, to expose or access organs or tissues for examination or intervention. The instrument consists of a blunt-edged, non-adjustable flat blade that curves near the distal tip, with a solid handle at the proximal end. The surgeon or assistant uses this instrument to manually pull the edge of the incision open. It is made of high-grade stainless steel and is available in a variety of blade lengths. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method

Contacts

PhoneEmail
781-221-2266csus@lemaitre.com

Regulatory Flags

DUNS number
184805166
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

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