FDA.report

NAMIC

Primary DI
10193489067149
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
80519412
Catalog number
80519412
Device description
ES07638 REV C - TARGET (80519412) PG
Published
2021-05-12
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

Product Codes

CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions

SubmissionSupplement
K903606000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K903606000GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCERNorth American Instrument Corp.1990-09-27LIT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489067146PrimaryGS10
10193489067149Unit of UseGS10

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
200
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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06091403562732Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562749Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562756Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562763Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562770Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562787Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562794Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562800Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562817Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562824Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562831Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562848Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562855Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562862Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562879Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562886Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562893Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
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06091403562916Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29