FDA.reportPublic FDA data

MERSILENE

Primary DI
10705031470507
Brand
MERSILENE
Company
ETHICON, LLC
Model
RS21XN
Catalog number
RS21XN
Device description
White Woven Polyester Fiber, Nonabsorbable Surgical Ligature
Published
2023-05-30
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
KDCINSTRUMENT, SURGICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KDCInstrument, Surgical, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20705031470504PackageGS16In Commercial Distribution
10705031470507PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2070503147050420705031470504
1070503147050710705031470507

GMDN Terms#

Term, Definition table
TermDefinition
Surgical support tape, non-bioabsorbableA band or cord intended to be used during surgery for the approximation, cerclage, fixation, retraction, ligation, and/or suspension of internal anatomical structures; some types may be used for connecting and supporting bone and/or ligaments and tendons. The device is typically made of a synthetic material (e.g., polyester, nylon, silicone) or cotton, is available in a variety of lengths and widths, and may be left in situ. This is a device that cannot be chemically degraded or absorbed via natural body processes. Disposable devices associated with implantation may be included. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(877)384-4266xxx@xxx.xxx

Regulatory Flags#

DUNS number
829465157
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705031064669MERSILENEF1506F15062026-08-25
10705031064683MERSILENEF1532F15322026-08-25
10705031064706MERSILENEF1534F15342026-08-25
10705031064805MERSILENEF2502F25022026-08-25
10705031064812MERSILENEF2503F25032026-08-25
10705031064904MERSILENEF2515F25152026-08-25
10705031064959MERSILENEF2520F25202026-08-25
10705031064973MERSILENEF2525F25252026-08-25
10705031065185MERSILENEF2570F25702026-08-25
10705031065369MERSILENEFR832FR8322026-08-25
10705031089020ETHILON2871G2871G2026-08-25
10705031096479ETHILONEH7436GEH7436G2026-08-25
10705031097421MERSILENEEH7638HEH7638H2026-08-25
10705031097599MERSILENEEH7684HEH7684H2026-08-25
10705031097865MERSILENEEH7750HEH7750H2026-08-25
10705031241060MERSILENEF1533HF1533H2026-08-25
10705031241077MERSILENEF2506HF2506H2026-08-25
10705031241107MERSILENEF2514HF2514H2026-08-25
10705031241114MERSILENEF2516HF2516H2026-08-25
10705031241138MERSILENEF2520HF2520H2026-08-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160528297Medical Action IndustriesMEDICAL ACTION INDUSTRIES INC.KDC2026-07-31
00749756402699DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402705DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402750DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402767DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402781DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402798DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
00749756402910DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-22
B504GS80200VericelProvisionKDC2026-07-20
B504GS80210VericelProvisionKDC2026-07-20
B504GS80220VericelProvisionKDC2026-07-20
00749756402545DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402552DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402569DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402576DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402583DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402590DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402606DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402613DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402620DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402637DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402644DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402651DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402675DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402682DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402712DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402729DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402736DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402743DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08
00749756402774DeRoyalDEROYAL INDUSTRIES, INC.KDC2026-07-08