FDA.reportPublic FDA data

ELMED INCORPORATED

Primary DI
00198506090844
Brand
ELMED INCORPORATED
Company
ELMED INCORPORATED
Model
B9941 FS-AN
Catalog number
B9941 FS-AN
Device description
"1 1/2"" (38MM) X 6"" (150MM), ELMED FIBER OPTIC BRITETRAC RETRACTOR, BLUE SILICONE HANDLE, RIGHT ANGLE TIP SMOOTH W/ SUCTION"
Published
2026-05-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00198506090844PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506090844001985060908441985060908440198506090844

GMDN Terms#

Term, Definition table
TermDefinition
Hand-held surgical retractor, reusableA hand-held, non-self-retaining 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 dedicated to ophthalmic surgery or small nerve/vessel retraction, but may otherwise be clinically dedicated. It includes a shaped/hooked blade with a handle/holding portion and is available in a wide variety of designs, such as a double- or single-ended blade that may be fenestrated (pronged); deep wound retractors are typically designed with a long, curved blade that may also be intended to retract organs; it may include a light. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags#

DUNS number
049290364
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
00842180192515ELMEDST180831ST1808312024-04-10
00842180167766ELMED18-083118-08312023-04-21
00198506090967ELMED INCORPORATED37120-3537120-352026-05-26
00198506090974ELMED INCORPORATEDSTE36101ESTE36101E2026-05-26
00198506090981ELMED INCORPORATEDSTE3641ESTE3641E2026-05-26
00198506090998ELMED INCORPORATEDSTE245013STE2450132026-05-26
00198506091001ELMED INCORPORATEDSTE245014STE2450142026-05-26
00198506091018ELMED INCORPORATEDSTE245015STE2450152026-05-26
00198506091025ELMED INCORPORATEDSTE245016STE2450162026-05-26
00198506091032ELMED INCORPORATEDSTE245017STE2450172026-05-26
00198506091049ELMED INCORPORATEDSTE245018STE2450182026-05-26
00198506091056ELMED INCORPORATEDSTE245019STE2450192026-05-26
00198506091063ELMED INCORPORATEDSTE245020STE2450202026-05-26
00198506091070ELMED INCORPORATEDSTE245021STE2450212026-05-26
00198506091087ELMED INCORPORATEDSTE245022STE2450222026-05-26
00198506091100ELMED INCORPORATEDSTE322924ISTE322924I2026-05-26
00198506091117ELMED INCORPORATEDSTE322923ISTE322923I2026-05-26
00198506091124ELMED INCORPORATEDSTE3211221ESTE3211221E2026-05-26
00198506090899ELMED INCORPORATEDSM13600-10SM13600-102026-05-19
00198506090905ELMED INCORPORATED33370-2733370-272026-05-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846159040272SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040289SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040296SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040302SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040319SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040326SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040333SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040340SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040357SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040364SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
00846159040371SCANLAN® RetractorSCANLAN INTERNATIONAL INCGAD2026-06-02
B7687425470Buxton BioMedicalBuxton Biomedical IncGAD2026-06-02
B7687425570Buxton BioMedicalBuxton Biomedical IncGAD2026-06-02
00810055254897Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055254903Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258871Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258888Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258895Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258901Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258918Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258925Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258932Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258956Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258963Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258970Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258987Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055258994Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259007Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259014Surgical DesignSurgical Design, Inc.GAD2026-06-01
00810055259021Surgical DesignSurgical Design, Inc.GAD2026-06-01