FDA.reportPublic FDA data

Wiggins Medical

Primary DI
00840217908856
Brand
Wiggins Medical
Company
Ebner Medical, LLC
Model
52-482-02ELCB
Catalog number
52-482-02ELCB
Device description
"Black Rotating Kerrison Shaft With Ejector (Use W 52-400-00B Handle) 40° Up Slight Curve Thin Footplate 2mm 8"""
Published
2024-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAERongeur, Manual

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAERongeur, ManualNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200383000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200383000Wiggins Medical Surgical InstrumentsWiggins Medical2020-07-21HAE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217908856PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217908856008402179088568402179088560840217908856

GMDN Terms#

Term, Definition table
TermDefinition
Spinal rongeurA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (intervertebral disk) or bone, through a cutting/biting action, during open spinal surgery (e.g., laminectomy, discectomy). It is typically made of metal and designed to withstand the forces required to bite over tough tissue. It is not intended for endoscopic access. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Inch
Width2Millimeter

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
Serial number
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
00190776432331MillenniumAvalign Technologies, Inc.HAE2026-09-24
04250325493537VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301713VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968301751VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301836VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968301843VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968302116VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968302147VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
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04255968302161VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302178VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302185VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302192VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22
04255968302260VitalitecVitalitec International Medizintechnik GmbHHAE2026-09-22