Guide Glide II® Guidewire Introducer Needle

Primary DI
M661S01318275
Brand
Guide Glide II® Guidewire Introducer Needle
Company
Spectra Medical Devices, LLC
Model
S01318-2.759LF
Device description
Guide Glide II® Guidewire Introducer Needle One-Wall Style, Pink Plastic Hub, B-Bevel Echogenic Tip, Lubricated, Bevel Indicator 18G (0.12 cm) x 2.75 in. (7.0 cm) Accepts guidewire up to 0.038 in. (0.96 mm)
Published
2023-10-13
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

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082580000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082580000SPECTRA GUIDEWIRE INTRODUCER NEEDLESpectra Medical Devices, Inc.2008-12-08DYB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M661S01318275PrimaryHIBCC0

Regulatory Flags#

DUNS number
118301171
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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M661S013182759Guidewire Introducer NeedleS013182759L2024-06-18
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M661S075183501Plastic Standard Hub Tuohy Epidural NeedleS07518-3.501B2024-06-18
M661S075185001Plastic Standard Hub Tuohy Epidural NeedleS07518-5.001B2024-06-18
M661S135143508Metal Standard Hub Tuohy Epidural NeedleS13514-3.508C2024-06-18
M661S135144008Metal Standard Hub Tuohy Epidural NeedleS13514-4.008C2024-06-18
M661S135173008Metal Standard Hub Tuohy Epidural NeedleS13517-3.008B2024-06-18

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