FDA.reportPublic FDA data

Mini Shears

Primary DI
20884521066271
Brand
Mini Shears
Company
Covidien LP
Model
171305
Device description
Shears
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951589000MANUAL SURGICAL INSRUMENTUnited States Surgical, A Division of Tyco Healthc1995-05-03GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10884521066274PackageGS16Not in Commercial Distribution
20884521066271PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088452106627410884521066274
2088452106627120884521066271

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic scissors, reusableA hand-held rigid device used in combination with a dedicated endoscope and intended to cut tissue or sutures during an endoscopic procedure. It is typically constructed of stainless steel and is designed as a long pair of parallel sliding arms whose distal end is equipped with a pair of mechanical (i.e., not electrosurgical) cutting blades operated through a ringed handle at the proximal end. It is typically introduced into the body cavity through the working channel of the endoscope. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Fahrenheit130 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags#

DUNS number
058614483
Device count
1
Lot or batch
true
Expiration date on label
true

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