FDA.report

Syneture

Primary DI
20884521795461
Brand
Syneture
Company
Covidien LP
Model
US1753
Catalog number
US1753
Device description
Custom Suture Pack, (4) 8886322751, (1) 8886327131, (1) CL975, (1) GLS322, (2) GS62M, (2) SM5637, (1) VP557MX, (1) VP706MX, (1) VS870, (1) S193, (1) S195, (1) S317, (3) 8886867901, (1) CL843, (1) CL95
Published
2020-01-09
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

Contact Domains

Product Codes

CodeName
OVNSuture kit

Product Code Classifications

CodeDeviceSpecialtyClass
OVNSuture KitGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20884521795461PackageGS16In Commercial Distribution
10884521795464PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088452179546120884521795461
1088452179546410884521795464

GMDN Terms

TermDefinition
Suture kit, medicatedA collection of sterile instruments, dressings, and pharmaceuticals necessary to perform a suturing procedure. It typically includes a disinfectant, needles and various threads (sutures used to join the edges of a wound or incision by stitching), drapes, swabs, needle holder, and other single-use disposable devices. This device may be used in a wide variety of clinical settings and some types may be used for the removal of sutures. This is a single-use device.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit
Special Storage Condition, Specify00;

Sterilization Methods

Method

Contacts

PhoneEmail
+1(508)261-8000covidien.udi@covidien.com

Regulatory Flags

DUNS number
058614483
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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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