FDA.report

Anmuth Medical International

Primary DI
08403207004239
Brand
Anmuth Medical International
Company
Anmuth Medical International, LLC
Model
24-806-18
Catalog number
24-806-18
Device description
RIGBY Retractor 60x20mm 18cm/7"
Published
2024-04-10
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

Related Records

Product Codes

CodeName
GADRETRACTOR

Product Code Classifications

CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08403207004239PrimaryGS10

GMDN Terms

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.

Device Sizes

TypeValueUnit
Length7Inch

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(413)478-9876marc@anmuthmedical.com

Regulatory Flags

DUNS number
786500830
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
false
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 DIBrandModelCatalogPublished
08403207009500Anmuth Medical International39-110-0039-110-002025-06-09
08403207009517Anmuth Medical International39-112-0039-112-002025-06-09
08403207009524Anmuth Medical International39-138-0039-138-002025-06-09
08403207009579Anmuth Medical International39-172-0039-172-002025-06-09
08403207009647Anmuth Medical International39-311-2039-311-202025-06-09
08403207009807Anmuth Medical International39-525-0639-525-062025-06-09
08403207010032Anmuth Medical International39-539-0339-539-032025-06-09
08403207010162Anmuth Medical International39-546-54TC39-546-54TC2025-06-09
08403207010179Anmuth Medical International39-547-24TC39-547-24TC2025-06-09
08403207010261Anmuth Medical International39-557-2539-557-252025-06-09
08403207010278Anmuth Medical International39-559-40TC39-559-40TC2025-06-09
08403207010285Anmuth Medical International39-559-47TC39-559-47TC2025-06-09
08403207010292Anmuth Medical International39-560-57TC39-560-57TC2025-06-09
08403207010346Anmuth Medical International39-630-0039-630-002025-06-09
08403207010353Anmuth Medical International39-633-2039-633-202025-06-09
08403207010360Anmuth Medical International39-635-1739-635-172025-06-09
08403207010377Anmuth Medical International39-650-2339-650-232025-06-09
08403207010384Anmuth Medical International39-666-0639-666-062025-06-09
08403207009531Anmuth Medical International39-160-0039-160-002025-06-05
08403207009548Anmuth Medical International39-161-1339-161-132025-06-05

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00198506089763ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089770ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00198506089787ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-24
00841536148008ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-24
00190776418342MillenniumAvalign Technologies, Inc.GAD2026-03-23
00190776418359MillenniumAvalign Technologies, Inc.GAD2026-03-23
00198506089695ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-20
00199150062263Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062270Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00199150062287Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.GAD2026-03-20
00840277133427Innomed, Inc.INNOMED, INC.GAD2026-03-20
00198506055393ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-19
10885862648587EquinoxeExactech, Inc.GAD2026-03-19
10885862648594EquinoxeExactech, Inc.GAD2026-03-19
10885862661234N/AExactech, Inc.GAD2026-03-19
10885862661371NovationExactech, Inc.GAD2026-03-19
10885862661388NovationExactech, Inc.GAD2026-03-19
10885862661395NovationExactech, Inc.GAD2026-03-19
10885862661401NovationExactech, Inc.GAD2026-03-19
00198506089671ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00198506089688ELMED INCORPORATEDELMED INCORPORATEDGAD2026-03-17
00810123209996Adler Instrument CompanyAdler, Inc.GAD2026-03-17
00810220800027Adler Instrument CompanyAdler, Inc.GAD2026-03-17
20763000284897OctoBase™MEDTRONIC, INC.GAD2026-03-14
00841536147766ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147773ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00841536147780ThompsonTHOMPSON SURGICAL INSTRUMENTS, INC.GAD2026-03-13
00810158219298PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
00810158219342PRINCETONPrinceton Medical Group, Inc.GAD2026-03-12
M93074301120S0Life InstrumentsLife Instrument CorporationGAD2026-03-12