FDA.reportPublic FDA data

Thompson

Primary DI
00841536140200
Brand
Thompson
Company
THOMPSON SURGICAL INSTRUMENTS, INC.
Model
31123
Device description
Advantis Laparoscopic Steriliz
Published
2021-03-15
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841536140200PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841536140200008415361402008415361402000841536140200

GMDN Terms#

Term, Definition table
TermDefinition
Surgical retraction system, reusableA frame-like assembly of surgical instruments/devices intended to be used to create a self-locking, self-retaining mechanism to temporarily part tissue (e.g., hold the edges of an incision open) to expose internal tissues or organs for access during open surgery; is not intended for neurosurgery or ophthalmic surgery. It includes a mounting frame (e.g., bar, ring) and a number of detachable retracting blades, may include additional features (e.g., ratchet mechanisms, fibreoptic lights), and might be intended to be mounted to the operating table or be non-fixed. It is typically made of high-grade stainless steel and synthetic materials. 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
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
00841536148008Thompson100421702026-03-24
00841536147766Thompson100620002026-03-13
00841536147773Thompson100620012026-03-13
00841536147780Thompson100422292026-03-13
00841536147360Thompson100701412026-03-11
00841536147377Thompson100701422026-03-11
00841536147667Thompson100701742026-03-11
00841536147346Thompson100701562026-03-10
00841536147384Thompson100701402026-03-10
00841536147391Thompson100701432026-03-10
00841536147407Thompson100701442026-03-10
00841536147438Thompson100701542026-03-10
00841536147339Thompson100701552026-03-09
00841536147650Thompson100701732026-03-06
00841536148206Thompson100SL46520EBLC2026-03-03
00841536148213Thompson100SL46524EBLC2026-03-03
00841536148220Thompson100SL46528EBLC2026-03-03
00841536148183Thompson100SL46512EBLC2026-03-02
00841536148190Thompson100SL46516EBLC2026-03-02
00841536147483Thompson100701572026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091100ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00198506091117ELMED INCORPORATEDELMED INCORPORATEDGAD2026-05-26
00810220800164Adler Instrument CompanyAdler, Inc.GAD2026-05-26
00850016403049ActivSight Imaging Module Clean and Disinfect TrayActiv Surgical, Inc.KCT2026-05-26
00850016403063ActivSight Light Cable Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00850016403070ActivSight Imaging Module Tray for VHPActiv Surgical, Inc.KCT2026-05-26
00850016403193ActivSight Laparoscope Sterilization TrayActiv Surgical, Inc.KCT2026-05-26
00857387006534Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00857387006541Stryker Universal Select Sterilization Tray SystemPARAGON MEDICAL, INC.KCT2026-05-26
00199150071685Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071692Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071708Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071715Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071722Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071746Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071753Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071760Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071777Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071784Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071791Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071807Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150071814Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-24
00199150076444Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-05-23
00810143905779SURGIPROSSurgipros, LLCGAD2026-05-23
00810212930480SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930510SURGIPROSSurgipros, LLCGAD2026-05-22
00810212930534SURGIPROSSurgipros, LLCGAD2026-05-22
M209232580Hintermann CompressorBIOPRO, INC.GAD2026-05-22
M209232590Hintermann DistractorBIOPRO, INC.GAD2026-05-22