FDA.reportPublic FDA data

COROLENE®

Primary DI
03661522102510
Brand
COROLENE®
Company
PETERS SURGICAL
Model
20N20K
Published
2026-03-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

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
K052701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K052701000COROLENEPeters Surgical2005-12-13GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03661522102510PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03661522102510036615221025103661522102510

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
265741780
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03661522011782CARDIOXYL ®73S15B2020-01-04
03661522011805CARDIOXYL ®73P30A2020-01-04
03661522011812CARDIOXYL ®73P30B2020-01-04
03661522011829CARDIOXYL ®73P30D2020-01-04
03661522011836CARDIOXYL ®73P30E2020-01-04
03661522011843CARDIOXYL ®73P30F2020-01-04
03661522011850CARDIOXYL ®73P30G2020-01-04
03661522011867CARDIOXYL ®73P30I2020-01-04
03661522011874CARDIOXYL ®73P30J2020-01-04
03661522011881CARDIOXYL ®73P30K2020-01-04
03661522011898CARDIOXYL ®73P30L2020-01-04
03661522011904CARDIOXYL ®73P30O2020-01-04
03661522011911CARDIOXYL ®73P30P2020-01-04
03661522011928CARDIOXYL ®73P30Q2020-01-04
03661522011935CARDIOXYL ®73P30R2020-01-04
03661522011942CARDIOXYL ®73P30S2020-01-04
03661522011959CARDIOXYL ®73P30T2020-01-04
03661522011966CARDIOXYL ®73S15C2020-01-04
03661522011973CARDIOXYL ®73S20A2020-01-04
03661522011980CARDIOXYL ®73S20B2020-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08903837224538TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837224552TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
08903837337238TruleneHEALTHIUM MEDTECH LIMITEDGAW2026-08-19
10705031091412PROLENEETHICON, LLCGAW2026-08-17
10705031091467PROLENEETHICON, LLCGAW2026-08-17
10705031091474PROLENEETHICON, LLCGAW2026-08-17
10705031091764PROLENEETHICON, LLCGAW2026-08-17
10705031095045PROLENEETHICON, LLCGAW2026-08-17
10705031095359PROLENEETHICON, LLCGAW2026-08-17
10705031096325PROLENEETHICON, LLCGAW2026-08-17
10705031097278PROLENEETHICON, LLCGAW2026-08-17
10705031097643PROLENEETHICON, LLCGAW2026-08-17
10705031097698PROLENEETHICON, LLCGAW2026-08-17
10705031097896PROLENEETHICON, LLCGAW2026-08-17
10705031097919PROLENEETHICON, LLCGAW2026-08-17
10705031097995PROLENEETHICON, LLCGAW2026-08-17
10705031098008PROLENEETHICON, LLCGAW2026-08-17
10705031098039PROLENEETHICON, LLCGAW2026-08-17
10705031127838PROLENEETHICON, LLCGAW2026-08-17
10705031128491PROLENEETHICON, LLCGAW2026-08-17
10705031132641PROLENEETHICON, LLCGAW2026-08-17
10705031148284PROLENEETHICON, LLCGAW2026-08-17
10705031148314PROLENEETHICON, LLCGAW2026-08-17
10705031148697PROLENEETHICON, LLCGAW2026-08-17
10705031201965PROLENEETHICON, LLCGAW2026-08-17
10705031201989PROLENEETHICON, LLCGAW2026-08-17
10705031238251PROLENEETHICON, LLCGAW2026-08-17
10705031464995PROLENEETHICON, LLCGAW2026-08-17
10705031465015PROLENEETHICON, LLCGAW2026-08-17