FDA.report

PTFE Guidewire 0.038" (0.97mm) x 150cm Regular Body, 3cm Straight Tip

Primary DI
00821925010383
Brand
PTFE Guidewire 0.038" (0.97mm) x 150cm Regular Body, 3cm Straight Tip
Company
Gyrus Acmi, Inc.
Model
28BX
Published
2018-09-11
Public version status
New
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
EYASTYLET, URETERAL

Product Code Classifications

CodeDeviceSpecialtyClass
EYAStylet, UreteralGastroenterology, Urology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00821925010383PackageGS15In Commercial Distribution
00821925003569PrimaryGS10

GMDN Terms

TermDefinition
Gastro-urological guidewire, single-useA sterile metal coil or wire intended to assist the insertion/positioning of a diagnostic/therapeutic device(s) [e.g., endoscope, catheter] within the gastrointestinal (GI) and/or urinary tract. It is typically coated with a plastic material [e.g., polytetrafluoroethylene (PTFE), commonly known as Teflon, or polyethylene (PE)]. It may have radiopaque graduated markings at the distal end to assist in the fluoroscopic monitoring of its advancement/position within the body. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
007198742
Device count
1
DM exempt
false
Premarket exempt
true
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
false
Sterilization required before use
false

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