FDA.reportPublic FDA data

Wiggins Medical

Primary DI
00840217910361
Brand
Wiggins Medical
Company
EBNER MEDICAL, LLC
Model
90-070-18FB
Device description
Black MIS Suction Retractor with Barrier Wings Small 2mm
Published
2026-08-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JZFTube, Ear Suction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZFTube, Ear SuctionEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217910361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217910361008402179103618402179103610840217910361

GMDN Terms#

Term, Definition table
TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
800-497-0851info@wigginsmedical.com

Regulatory Flags#

DUNS number
106135367
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840217910170Ace Medical CompanyAA4021010AA40210102026-08-13
00840217910187Ace Medical CompanyAA4021015AA40210152026-08-13
00840217910194Ace Medical CompanyAA4021023AA40210232026-08-13
00840217910200Ace Medical CompanyAA4021223AA40212232026-08-13
00840217910217Ace Medical CompanyAA4021215AA40212152026-08-13
00840217910224Ace Medical CompanyAA4021410AA40214102026-08-13
00840217910231Ace Medical CompanyAA4021415AA40214152026-08-13
00840217910248Ace Medical CompanyAA40214232026-08-13
00840217910255Ace Medical CompanyAA4021605AA40216052026-08-13
00840217910262Ace Medical CompanyAA4021608AA40216082026-08-13
00840217910279Ace Medical CompanyECA-A008ECA-A0082026-08-13
00840217910286Wiggins Medical90-070-25FB90-070-25FB2026-08-13
00840217910293Ace Medical CompanyER806.000PAER806.000PA2026-08-13
00840217910309Ace Medical CompanyER806.000VAER806.000VA2026-08-13
00840217910316Ace Medical CompanyER300.010ERER300.010ER2026-08-13
00840217910323Ace Medical CompanyER305.200ER1ER305.200ER12026-08-13
00840217910330Ace Medical CompanyER305.150EER305.150E2026-08-13
00840217910347Ace Medical CompanyER300.020BAER300.020BA2026-08-13
00840217910354Ace Medical CompanyER390.070ER390.0702026-08-13
00840217910378Ace Medical CompanyAA98118072026-08-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G1415712012650Carnegie Surgical LLCCarnegie Surgical LLCJZF2026-10-07
00190776423827MillenniumAvalign Technologies, Inc.JZF2026-08-26
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04054462904433evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904440evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904457evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904471evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904495evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904501evonosevonos GmbH & Co. KGJZF2026-08-21
04054462904518evonosevonos GmbH & Co. KGJZF2026-08-21