FDA.report

NAMIC

Primary DI
H74902470012
Brand
NAMIC
Company
NAVILYST MEDICAL, INC.
Model
0247001
Device description
The Grip Torque Device
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LOXCatheters, transluminal coronary angioplasty, percutaneous

Product Code Classifications

CodeDeviceSpecialtyClass
LOXCatheters, Transluminal Coronary Angioplasty, PercutaneousCardiovascular2

Premarket Submissions

SubmissionSupplement
K896108000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K896108000THE PILOT SCIMED TORQUE DEVICEScimed Life Systems, Inc.1990-01-09LOX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
H74902470012PackageHIBCC10In Commercial Distribution
H74902470010PrimaryHIBCC0

GMDN Terms

TermDefinition
Torque manipulation deviceA sterile hand-operated device intended to be attached to the proximal end of an invasive device (e.g., a catheter, a needle, or a guidewire) to provide the operator with the ability to manually manipulate and control the directional torque (rotation) of the device to which it is attached. This device may be made of plastic or metal materials. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags

DUNS number
809699023
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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