FDA.reportPublic FDA data

Polysorb

Primary DI
10884521103214
Brand
Polysorb
Company
Covidien LP
Model
SL-5621
Device description
Braided Absorbable Suture
Published
2015-09-02
Public version status
Update
Distribution status
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
GAMSUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAMSuture, Absorbable, Synthetic, Polyglycolic AcidGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K963253000
K981935000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K963253000SYNTHETIC ABSORBABLE SURGICAL SUTUREUnited States Surgical, A Division of Tyco Healthc1996-10-08GAM
K981935000POLYSORB SUTUREUnited States Surgical, A Division of Tyco Healthc1998-06-25GAM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521103211PackageGS136In Commercial Distribution
10884521103214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452110321120884521103211
1088452110321410884521103214

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic, bioabsorbable thread made from a polyester intended to join (approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues. The thread provides extended temporary wound support, until the wound sufficiently heals to withstand normal stress, and is subsequently absorbed by hydrolysis; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. It is not a barbed suture and does not include antimicrobial agents/materials. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length30Inch

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10884521543799SigniaSIGPSHELL2017-08-08
10884521856271Touch SurgeryMDS300012026-10-16
10884521701243INVOSPMAC71DOC2024-04-14
10884521810105INVOSPM71002021-06-14
10884521780170INVOSPMAC71DOC2019-07-31
10884521780071INVOSPM71002019-06-12
10884521839830TrexonCY904P2026-10-10
10884521839861TrexonCY954P2026-10-10
10884521840089TrexonCY811P2026-10-10
10884521840126TrexonCY843P2026-10-10
10884521840140TrexonCY883P2026-10-10
10884521840171TrexonCY953P2026-10-10
10884521840195TrexonGY123P2026-10-10
10884521840249TrexonGY323P2026-10-10
10884521840263TrexonSY823P2026-10-10
10884521840270TrexonSY923P2026-10-10
10884521840379TrexonGY122P2026-10-10
10884521840409TrexonGY322P2026-10-10
10884521840430TrexonSY5628P2026-10-10
10884521840447TrexonSY5638P2026-10-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10884521839861TrexonCovidien LPGAM2026-10-10
10884521840089TrexonCovidien LPGAM2026-10-10
10884521840126TrexonCovidien LPGAM2026-10-10
10884521840140TrexonCovidien LPGAM2026-10-10
10884521840171TrexonCovidien LPGAM2026-10-10
10884521840195TrexonCovidien LPGAM2026-10-10
10884521840249TrexonCovidien LPGAM2026-10-10
10884521840263TrexonCovidien LPGAM2026-10-10
10884521840270TrexonCovidien LPGAM2026-10-10
10884521840379TrexonCovidien LPGAM2026-10-10
10884521840409TrexonCovidien LPGAM2026-10-10
10884521840430TrexonCovidien LPGAM2026-10-10
10884521840447TrexonCovidien LPGAM2026-10-10
10884521840454TrexonCovidien LPGAM2026-10-10
10884521840461TrexonCovidien LPGAM2026-10-10
10884521840478TrexonCovidien LPGAM2026-10-10
10884521840485TrexonCovidien LPGAM2026-10-10
10884521840492TrexonCovidien LPGAM2026-10-10
10884521840508TrexonCovidien LPGAM2026-10-10
10884521840591TrexonCovidien LPGAM2026-10-10
10884521840614TrexonCovidien LPGAM2026-10-10
10884521840645TrexonCovidien LPGAM2026-10-10
10884521840652TrexonCovidien LPGAM2026-10-10
10884521840669TrexonCovidien LPGAM2026-10-10
10884521840676TrexonCovidien LPGAM2026-10-10
10884521840683TrexonCovidien LPGAM2026-10-10
10884521840690TrexonCovidien LPGAM2026-10-10
10884521840706TrexonCovidien LPGAM2026-10-10
10884521840720TrexonCovidien LPGAM2026-10-10