FDA.reportPublic FDA data

RAM® COR-SUTURE® QUICK LOAD®

Primary DI
10850200006404
Brand
RAM® COR-SUTURE® QUICK LOAD®
Company
LSI Solutions, Inc.
Model
022090
Device description
RAM® COR-SUTURE® QUICK LOAD® Pledgeted Surgical Suture 6-Tray - 2-0 Polyester, Sterile, Synthetic, Non-Absorbable, Coated, Braided, Surgical Suture, USP, 3.0 Metric, 38", 97 cm, 2 Ferrules, PTFE pledget, Green (3), White (3) Each sterile package contains a tray of (6) 2-0 Polyester Surgical Sutures, (3.0 Metric), 2 Ferrules, PTFE Pledget, 38" (97 cm), (3) Green and (3) White.
Published
2018-06-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GASSuture, Nonabsorbable, Synthetic, Polyester

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GASSuture, Nonabsorbable, Synthetic, PolyesterGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160529000Pledgeted COR-SUTURE QUICK LOADLsi Soultions2016-09-15GAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850200006404PackageGS16In Commercial Distribution
00850200006407PrimaryGS10
00850200006414Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085020000640410850200006404
00850200006407008502000064078502000064070850200006407
00850200006414008502000064148502000064140850200006414

GMDN Terms#

Term, Definition table
TermDefinition
Polyester suture, non-bioabsorbable, multifilamentA 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 needle intended to be disposed of after single use. 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 intended to be used in a sterile condition.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length38Inch
Outer Diameter0.32Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0260 Degrees Celsius
Storage Environment Temperature0500 Degrees Fahrenheit
Storage Environment Temperature0 Degrees Fahrenheit500 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-575-3493customerservice@lsisolutions.com
+1(866)575-3493customerservice@lsisolutions.com
+1(866)575-3493regulatorydpt@lsisolutions.com

Regulatory Flags#

DUNS number
603420183
Device count
6
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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850012846703PicoDriver0234700234702026-04-28
00850012846246MD™ QUICK LOAD®0231600231602022-12-22
00850012846529RD® QUICK LOAD®0233870233872025-07-09
00850012846543RAM® COR-SUTURE® QUICK LOAD®0234070234072025-07-28
00850200006148RD® QUICK LOAD®0209790209792015-12-04
00850200006346COR-SUTURE® QUICK LOAD®0218610218612016-05-12
00850200006353COR-SUTURE® QUICK LOAD®0218620218622016-05-12
00850200006407RAM® COR-SUTURE® QUICK LOAD®0220900220902018-06-02
00850200006438RAM® COR-SUTURE® QUICK LOAD®0220470220472018-06-02
00850200006445RAM® COR-SUTURE® QUICK LOAD®0220390220392020-03-13
00850200006452RAM® COR-SUTURE® QUICK LOAD®0223350223352020-03-13
00850200006469RAM® COR-SUTURE® QUICK LOAD®0223200223202020-03-13
00850200006476RAM® COR-SUTURE® QUICK LOAD®0223250223252020-03-13
00850200006483RAM® COR-SUTURE® QUICK LOAD®0223400223402020-03-13
00850200006766RAM® COR-SUTURE® QUICK LOAD®0226680226682020-03-13
00850200006773RAM® COR-SUTURE® QUICK LOAD®0226710226712020-03-13
00850200006780RAM® COR-SUTURE® QUICK LOAD®0226740226742020-03-13
00850200006797RAM® COR-SUTURE® QUICK LOAD®0226800226802020-03-13
00850200006803RAM® COR-SUTURE® QUICK LOAD®0226830226832020-03-13
00850200006810RAM® COR-SUTURE® QUICK LOAD®0226860226862020-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840124514126TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124514188TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124524774TopLockFUSION ORTHOPEDICS, LLCGAS2025-11-18
00840124521339TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521346TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521353TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00840124521360TopLockFUSION ORTHOPEDICS, LLCGAS2025-08-14
00850012846543RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
10850012846540RAM® COR-SUTURE® QUICK LOAD®LSI Solutions, Inc.GAS2025-07-28
00840277408389PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408396PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408402PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408419PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408426RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408433RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408440RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277408457RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409133PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409140PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409416RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
00840277409430RiverBondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408386PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408393PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408409PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408416PolybondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408423RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408430RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408447RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277408454RiverbondRIVERPOINT MEDICAL, LLCGAS2025-06-18
10840277409130PolyBondRIVERPOINT MEDICAL, LLCGAS2025-06-18