FDA.reportPublic FDA data

CARDIOXYL ®

Primary DI
03661522011843
Brand
CARDIOXYL ®
Company
PETERS SURGICAL
Model
73P30F
Published
2020-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GATSUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GATSuture, Nonabsorbable, Synthetic, PolyethyleneGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K060163000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060163000CARDIOFLON, CARDIOXYLPeters Surgical2006-10-11GAT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
13661522011840PackageGS112In Commercial Distribution
03661522011843PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1366152201184013661522011840
03661522011843036615220118433661522011843

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilament, non-antimicrobialA multiple-strand (multifilament), synthetic thread made from a non-bioabsorbable polyester 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.

Regulatory Flags#

DUNS number
265741780
Device count
1
Lot or batch
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
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
03661522011997CARDIOXYL ®73S20D2020-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07649990202419Drill S-PI-A1.6 extra shortSurgical Fusion Technologies GmbHGAT2026-01-18
07649990202174Geomax Reamer S-PI-A1.6Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202211Geomax Reamer S-PI-A2.3Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202372Geomax Reamer S-PI-A3.0Surgical Fusion Technologies GmbHGAT2025-10-01
07649990202389Handle SSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202396Geomax Reamer SetSurgical Fusion Technologies GmbHGAT2025-10-01
07649990202228SF Push-in Anchor 1.6Surgical Fusion Technologies GmbHGAT2024-04-12
07649990202303Sonotrode S-PISurgical Fusion Technologies GmbHGAT2024-04-12
07649990202204SupraFuser B GeneratorSurgical Fusion Technologies GmbHGAT2024-02-06
07649990202020Tray_SF Push-In Anchor 2.3Surgical Fusion Technologies GmbHGAT2024-01-10
07649990202181Handpiece Front CoverSurgical Fusion Technologies GmbHGAT2024-01-10
07649990202013Tray_SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202037Sonotrode PI-S 2.3Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202044Twist Drill PI-C 1.8Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202051Wrench 5.0Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202150BoneWelder 150-W1Surgical Fusion Technologies GmbHGAT2023-12-14
07649990202167SF Push-in Anchor 2.3Surgical Fusion Technologies GmbHGAT2023-12-08
10652927144151DemeBONDDemetech CorporationGAT2019-07-16
10652927144168DemeBONDDemetech CorporationGAT2019-07-16
10652927150312DemeBONDDemetech CorporationGAT2019-07-16
10652927158936DemeBONDDemetech CorporationGAT2019-07-16
10652927158943DemeBONDDemetech CorporationGAT2019-07-16
10652927158950DemeBONDDemetech CorporationGAT2019-07-16
10652927158967DemeBONDDemetech CorporationGAT2019-07-16
10652927158974DemeBONDDemetech CorporationGAT2019-07-16
10652927160878DemeBONDDemetech CorporationGAT2019-07-16
10652927160885DemeBONDDemetech CorporationGAT2019-07-16
10652927161134DemeBONDDemetech CorporationGAT2019-07-16
10652927161141DemeBONDDemetech CorporationGAT2019-07-16
10652927164562DemeBONDDemetech CorporationGAT2019-07-16