Purstring

Primary DI
20884521051437
Brand
Purstring
Company
Covidien LP
Model
020242
Catalog number
020242
Device description
Purse String Device
Published
2018-08-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
GDJCLAMP, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDJClamp, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K901107000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K901107000MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATICUnited States Surgical, A Division of Tyco Healthc1990-04-09GDJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521051437PackageGS13In Commercial Distribution
10884521051430PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452105143720884521051437
1088452105143010884521051430

GMDN Terms#

Term, Definition table
TermDefinition
Suture retention deviceA device designed to be placed on the surface of the skin and intended to aid wound healing by distributing suture tension over a larger area in the patient. It is typically in the form of a retention bridge, a surgical button, or a suture bolster through which the sutures are passed. The distribution of suture tension will help prevent the suture from cutting the skin. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length65Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00null;

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
058614483
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

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Primary DI, Brand, Model table
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10884521205444Shiley7CN80R2016-09-24
10884521205451Shiley8CN85R2016-09-24
10884521205468Shiley9CN90R2016-09-24
10884521205475Shiley10CN10R2016-09-24
10884521205482Shiley4UN65R2016-09-24
10884521205499Shiley5UN70R2016-09-24
10884521205505Shiley6UN75R2016-09-24
10884521205512Shiley7UN80R2016-09-24
10884521205529Shiley8UN85R2016-09-24
10884521205536Shiley9UN90R2016-09-24
10884521205543Shiley10UN10R2016-09-24
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10884521820913Mon-a-Therm900432023-05-29

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