FDA.reportPublic FDA data

Thompson

Primary DI
00841536108804
Brand
Thompson
Company
Thompson Surgical Instruments, Inc.
Model
43113
Device description
Large Basket 6 1/2in
Published
2020-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
DWSInstruments, Surgical, Cardiovascular
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWSInstruments, Surgical, CardiovascularCardiovascular1
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841536108804PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841536108804008415361088048415361088040841536108804

GMDN Terms#

Term, Definition table
TermDefinition
Self-retaining surgical retractor, reusableA hand-operated, self-retaining, one-piece 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 intended to retract the ribs and is not dedicated to ophthalmic surgery, but may otherwise be clinically dedicated. It is designed as a one-piece device (i.e., not a mounting ring, or table-fixed assembly) having two legs with distal hooked blades and a self-retaining mechanism to maintain the legs in an open position for retraction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
2316425603ken.gmoser@thompsonsurgical.com

Regulatory Flags#

DUNS number
081334746
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841536146516Thompson50000SFAB2025-09-10
00841536146523Thompson50000SFAT2025-09-10
00841536148435ThompsonSL71252026-05-14
00841536148244Thompson100650122026-05-13
00841536148251Thompson100650142026-05-13
00841536148268Thompson100650162026-05-13
00841536147025Thompson650122026-05-12
00841536147032Thompson650142026-05-12
00841536147049Thompson650162026-05-12
00841536148428Thompson71202026-05-11
00841536147018Thompson600262026-05-06
00841536147056Thompson650102026-05-06
00841536105834Thompson66202022-06-23
00841536105858Thompson66242022-06-23
00841536105865Thompson66232022-06-23
00841536105889Thompson66252022-06-23
00841536126167Thompson66632022-06-23
00841536126174Thompson66642022-06-23
00841536126181Thompson66652022-06-23
00841536126228Thompson66612022-06-23

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08022057015877JOSEPH LAMELAS Knot PusherCORCYM SRLDWS2026-02-03
07640332476321SCARLET AL-T INSTRUMENTATIONSpineArt SAGAD2025-11-10
07640375234681PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234698PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234704PERLA ® TL MISSpineArt SAGAD2025-11-10
07640375234711PERLA ® TL MISSpineArt SAGAD2025-11-10
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08904332600698MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600704MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
08904332600711MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-11-04
G453TR251320PEAK MEDICALPeak Medical Distribution Inc.GAD2025-10-15
08800071700487Tiger ViewKims Med Co.,Ltd.GAD2025-10-15
08800071017240SignexOSTEONIC CO.,Ltd.GAD2025-06-24
08904332600582MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600599MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600605MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
08904332600612MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-05-13
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08904332600476MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600483MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08904332600490MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGAD2025-03-10
08800071700357Tiger ViewKims Med Co.,Ltd.GAD2025-02-10
08800071700371Tiger View Kims Med Co.,Ltd.GAD2025-02-10
08800071700395Tiger View Kims Med Co.,Ltd.GAD2025-02-10
G141549052210Carnegie Surgical LLCCarnegie Surgical LLCGAD2025-01-17