Premium Multifire TA

Primary DI
10884521045965
Brand
Premium Multifire TA
Company
Covidien LP
Model
010315
Catalog number
010315
Device description
Vascular Stapler
Published
2018-08-10
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
FHMAPPARATUS, SUTURING, STOMACH AND INTESTINAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FHMApparatus, Suturing, Stomach And IntestinalGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K801589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K801589000AUTO SUTURE DISP. 30, ETC. & SURG. STAPUnited States Surgical, A Division of Tyco Healthc1980-08-04FHM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521045962PackageGS13Not in Commercial Distribution
10884521045965PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452104596220884521045962
1088452104596510884521045965

GMDN Terms#

Term, Definition table
TermDefinition
Open-surgery manual linear stapler, single-useA sterile, hand-held, manual surgical instrument intended to be used during open surgery (including abdominal, gynaecological, paediatric, or thoracic surgery) for the application of surgical staples to approximate internal soft tissues (e.g., two ends of bowel) or for fixation of a surgical mesh to tissue. The device operates by a manual mechanism (e.g., lever, sliding knob) whereby it applies single or multiple linear rows of surgical staples to a portion of tissue; it has no cutting function. The staples may be housed in a single-use loading unit (SULU) which may be included. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length30Millimeter

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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