FDA.reportPublic FDA data

Ebner

Primary DI
00840217907712
Brand
Ebner
Company
Ebner Medical, LLC
Model
26.768.11
Catalog number
26.768.11
Device description
Converse Nose Retractor 10.5cm, 44x11 mm
Published
2023-06-07
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217907712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217907712008402179077128402179077120840217907712

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10.5Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
106135367
Device count
1
DM exempt
true
Premarket exempt
true
Serial number
true
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840217910101EBNER MEDICALER300.020BAER300.020BA2025-12-10
00840217910118EBNER MEDICALER305.150EER305.150E2025-12-10
00840217910125Wiggins medical90-403-0190-403-012025-12-10
00840217910132Wiggins medical90-403-022025-12-10
00840217910149Wiggins medical90-403-032025-12-10
00840217910156Wiggins medical90-403-042025-12-10
00840217910163Wiggins medical90-403-052025-12-10
00840217910095Wiggins Medical90-050-18/142B90-050-18/142B2025-11-18
00840217910071Wiggins Medical90-055-52/92B90-055-52/92B2025-10-17
00840217910088Wiggins Medical90-055-52/142B90-055-52/142B2025-10-17
00840217910064Ace Medical CompanyEE1014030EE10140302025-10-14
00840217910033Ace Medical CompanyRBC-TrayRBC-Tray2025-10-08
00840217910040Ace Medical CompanyFETOSCOPIC-TrayFETOSCOPIC-Tray2025-10-08
00840217910057Ace Medical CompanyFCS-TrayFCS-Tray2025-10-08
10840217910009Ace Medical CompanySW001-Box-52025-10-07
20840217910006Ace Medical CompanySW001-Box-102025-10-07
00840217910002Ace Medical CompanySW001-Box12025-10-07
00840217909914Wiggins Medical90-055-18/142B90-055-18/142B2025-09-24
00840217909921Wiggins Medical90-060-36/92B90-060-36/92B2025-09-24
00840217909938Wiggins Medical90-060-36/142B90-060-36/142B2025-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776395483MillenniumAvalign Technologies, Inc.GAD2026-07-14
B382SD123750Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123760Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD123780Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD124326191140Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209910FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209920FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD209923FSANT0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907126105T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247080T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907247112T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD90724711T0Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907249100Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907284670Surgical DirectSurgical Direct, Inc.GAD2026-07-14
B382SD907337510Surgical DirectSurgical Direct, Inc.GAD2026-07-14
G453152901750PEAK MEDICALPeak Medical Distribution Inc.GAD2026-07-14
00198506091872ELMED INCORPORATEDELMED INCORPORATEDGAD2026-07-10
00810158211193PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00810158219861PRINCETONPrinceton Medical Group, Inc.GAD2026-07-10
00888937033687ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033694ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033700ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033717ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033724ONETRACCoopersurgical, Inc.GAD2026-07-10
00888937033731ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033748ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033755ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033762ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033779ONETRAC LXCoopersurgical, Inc.GAD2026-07-10
00888937033786ONETRAC™ LXSCoopersurgical, Inc.GAD2026-07-10