FDA.reportPublic FDA data

Wiggins Medical

Primary DI
00840217904421
Brand
Wiggins Medical
Company
Ebner Medical, LLC
Model
52-106-40/36B
Catalog number
52-106-40/36B
Device description
"Black Caspar-style IVD Rongeur w/teeth, 4mm down, 14"""
Published
2021-05-20
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
HTXRongeur

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840217904421PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217904421008402179044218402179044210840217904421

GMDN Terms#

Term, Definition table
TermDefinition
Craniofacial rongeur, reusableA hand-held manual surgical instrument with sharp, scoop-shaped jaws designed for cutting tough tissues (cartilage, sinew) or bone, through a cutting/biting action, during surgery involving the cranium and/or face (e.g., craniotomy, ethmoidectomy, mastoidectomy, rhinoplasty); it is not dedicated to dental surgery. It is typically made of metal and designed to withstand the forces required to bite over tough/hard tissue. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Inch
Width4Millimeter

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
Premarket exempt
true
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
B382SD914800210Surgical DirectSurgical Direct, Inc.HTX2026-09-30
B382SD30550860Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD546210000Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131060Surgical DirectSurgical Direct, Inc.HTX2026-09-29
B382SD9228131070Surgical DirectSurgical Direct, Inc.HTX2026-09-29
00190776432546MillenniumAvalign Technologies, Inc.HTX2026-09-28
00724995267902Snowden-PencerSTERIS Deutschland GmbHHTX2026-09-25
00724995274597V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321390V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321406V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321413V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00724995321420V. MuellerSTERIS Deutschland GmbHHTX2026-09-25
00190776431105MillenniumAvalign Technologies, Inc.HTX2026-09-21
00190776427955MillenniumAvalign Technologies, Inc.HTX2026-08-27
00190776427962MillenniumAvalign Technologies, Inc.HTX2026-08-27
00192896122048Ceramitec Universal Klick Ferris Smith Rongeur ShaftSONTEC INSTRUMENTS, INC.HTX2026-08-25
B382SD9227656000Surgical DirectSurgical Direct, Inc.HTX2026-08-21
00190776426682MillenniumAvalign Technologies, Inc.HTX2026-08-19
00190776426699MillenniumAvalign Technologies, Inc.HTX2026-08-19
B382SD922812030Surgical DirectSurgical Direct, Inc.HTX2026-08-07
00190776422912MillenniumAvalign Technologies, Inc.HTX2026-08-03
00190776422929MillenniumAvalign Technologies, Inc.HTX2026-08-03
B382SD4319D0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480007LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD480046220Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482030LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482047PH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482058LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482505LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03
B382SD482506LH0Surgical DirectSurgical Direct, Inc.HTX2026-08-03