FDA.reportPublic FDA data

Thompson

Primary DI
00841536119466
Brand
Thompson
Company
Thompson Surgical Instruments, Inc.
Model
51229
Device description
Sals Tip Stylet
Published
2020-08-06
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
GADRetractor
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841536119466PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841536119466008415361194668415361194660841536119466

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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