FDA.reportPublic FDA data

Surgipro II

Primary DI
10884521813007
Brand
Surgipro II
Company
Covidien LP
Model
X1402
Device description
Monofilament Polypropylene Nonabsorbable Suture
Published
2021-08-27
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
GAWSuture, nonabsorbable, synthetic, polypropylene

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAWSuture, Nonabsorbable, Synthetic, PolypropyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K954808000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K954808000USSC POLYPROPLENE SUTUREUnited States Surgical, A Division of Tyco Healthc1996-02-27GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20884521813004PackageGS136Not in Commercial Distribution
10884521813007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452181300420884521813004
1088452181300710884521813007

GMDN Terms#

Term, Definition table
TermDefinition
Polyolefin/fluoropolymer suture, monofilamentA single-strand (monofilament), synthetic, non-bioabsorbable thread made of a polyolefin (e.g., polypropylene, polyethylene) or fluoropolymer (e.g., polytetrafluoroethylene, polyvinylidene fluoride) intended to join (i.e., approximate) the edges of a soft-tissue wound or incision by stitching or to ligate soft tissues; it may include an attached disposable device(s) [e.g., needle, passer] intended to facilitate suture application. The thread provides temporary wound support until the wound sufficiently heals to withstand normal stress. 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

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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
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