FDA.report

Wiggins Medical

Primary DI
00840217903462
Brand
Wiggins Medical
Company
Ebner Medical
Model
51-011-15/15B
Catalog number
51-011-15/15B
Device description
Black Decker (1.5mm x 6mm cup) straight, 6"
Published
2021-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
HTXRongeur

Product Code Classifications

CodeDeviceSpecialtyClass
HTXRongeurOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840217903462PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840217903462008402179034628402179034620840217903462

GMDN Terms

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

TypeValueUnit
Length6Inch
Width1.5Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
true
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 DIBrandModelCatalogPublished
00840217908603Ace Medical CompanyACEBAY07-20TCACEBAY07-20TC2024-01-16
00840217908610Ace Medical CompanyACEDET08-30SACEDET08-30S2024-01-16
00840217908504Wiggins Medical52-731-01B52-731-01B2024-01-05
00840217908511Wiggins Medical52-731-02EB52-731-02EB2024-01-05
00840217908528Wiggins Medical52-731-03EB52-731-03EB2024-01-05
00840217908535Wiggins Medical52-731-04EB52-731-04EB2024-01-05
00840217908542Wiggins Medical52-731-05EB52-731-05EB2024-01-05
00840217908481Ace Medical AA9772020AA97720202023-12-26
00840217908498Ace Medical AA9772030AA97720302023-12-26
00840217907941ACE MedicalAA9781230AA97812302023-12-16
00840217908009Ace Medical CoAA9824023AA98240232023-07-13
00840217908474Wiggins Medical52-741-01B2023-11-09
00840217908443Wiggins Medical52-742-02SPFB2023-11-03
00840217908436Ace Medical CompanyECA-C0012023-10-25
00840217908399Ace Medical CompanyCNA-15L202023-10-23
00840217908405Ace Medical CompanyCMI-20L252023-10-23
00840217908412Ace Medical CompanyECA-C0282023-10-23
00840217908429Ace Medical CompanyECA-C0292023-10-23
00840217908382Ace Medical CoEE7033530V2023-09-29
00840217908368Ace Medical CompanyAA66620902023-09-01

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