FDA.report

EASY MOUNTER

Primary DI
D7701489323
Brand
EASY MOUNTER
Company
SWEDEN & MARTINA SPA
Model
GS-EASYPE-L-415-EX
Catalog number
GS-EASYPE-L-415-EX
Device description
EASY MOUNTER PRAMA HEX, POST EXTRACT, SLEEVE 415
Published
2021-06-22
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
true

Related Records

Contact Domains

Product Codes

CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications

CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D7701489323PrimaryHIBCC0

GMDN Terms

TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
844.862.7846info.us@sweden-martina.com

Regulatory Flags

DUNS number
433815198
Device count
1
DM exempt
true
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
D7702749733MASTER SLEEVEGS-B-50WGS-B-50W2025-12-16
D7702749743MASTER SLEEVEGS-B-50W-6GS-B-50W-62025-12-16
D7702749753MASTER SLEEVEGS-B-50W-SETGS-B-50W-SET2025-12-16
D7702707123STARTER PACK B4USTARTER-PACK-B4U.STARTER-PACK-B4U.2025-09-26
D7701556003PRAMA RF IMPLANT ZIRTILS-ZT-380SL-180LS-ZT-380SL-1802025-08-04
D7701556073PRAMA RF IMPLANT ZIRTILS-ZT-425SL-180LS-ZT-425SL-1802025-08-04
D7701609403STOP FOR CONICAL DRILL STOP-2025-180-SWSTOP-2025-180-SW2025-07-24
D7701609413STOP FOR CONICAL DRILL STOP-2025-190-SWSTOP-2025-190-SW2025-07-24
D7701609433STOP FOR CONICAL DRILL STOP-2025-210-SWSTOP-2025-210-SW2025-07-24
D7701609443STOP FOR CONICAL DRILL STOP-2025-220-SWSTOP-2025-220-SW2025-07-24
D7701609463STOP FOR CONICAL DRILL STOP-2025-240-SWSTOP-2025-240-SW2025-07-24
D7701609483STOP FOR CONICAL DRILL STOP-2025-260-SWSTOP-2025-260-SW2025-07-24
D7701609513CYLINDRICAL DRILLFP-200-L-SWFP-200-L-SW2025-07-24
D7701609523CONICAL DRILLFK250-L-SWFK250-L-SW2025-07-24
D7701609693FINAL CONICAL DRILLFK380-L-SWFK380-L-SW2025-07-24
D7701609703FINAL CONICAL DRILLFK425-L-SWFK425-L-SW2025-07-24
D7701609733STOP FOR CONICAL DRILL STOP-3842-180-SWSTOP-3842-180-SW2025-07-24
D7701609743STOP FOR CONICAL DRILL STOP-3842-190-SWSTOP-3842-190-SW2025-07-24
D7701609763STOP FOR CONICAL DRILL STOP-3842-210-SWSTOP-3842-210-SW2025-07-24
D7701609773STOP FOR CONICAL DRILL STOP-3842-220-SWSTOP-3842-220-SW2025-07-24

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