FDA.reportPublic FDA data

Minuteman

Primary DI
M9432001320000
Brand
Minuteman
Company
Spinal Simplicity, LLC
Model
20-0132-000
Device description
Wiltse-Gelpi Retractor 28cm
Published
2023-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M9432001320000PrimaryHIBCC0

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

Regulatory Flags#

DUNS number
963359513
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M9433500130000Freedom DS35-0013-0002026-05-07
M9432002100000Minuteman20-0210-0002026-05-05
M9432002110000Minuteman 20-0211-0002026-05-05
M9432002120000Minuteman 20-0212-0002026-05-05
M9432002130000Minuteman 20-0213-0002026-05-05
M9432002140000Minuteman 20-0214-0002026-05-05
M9432002160000Minuteman20-0216-0002026-05-05
M9432002170000Minuteman 20-0217-0002026-05-05
M9432002180000Minuteman 20-0218-0002026-05-05
M9432002190000Minuteman 20-0219-0002026-05-05
M9432002210000Minuteman 20-0221-0002026-05-05
M9433000290000Minuteman30-0029-0002026-05-05
M9433500120000Minuteman 35-0012-0002026-05-05
M9431002200000Minuteman 10-0220-0002026-02-23
M9431002210000Minuteman 10-0221-0002026-02-23
M9431002220000Minuteman 10-0222-0002026-02-23
M9431002230000Minuteman 10-0223-0002026-02-23
M9431002240000Minuteman 10-0224-0002026-02-23
M9432001910000Patriot SI20-0191-0002024-05-13
M9438000060000Liberty SI80-0006-0002025-11-17

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10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
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