FDA.reportPublic FDA data

Umbilical Tape

Primary DI
00840277405791
Brand
Umbilical Tape
Company
RIVERPOINT MEDICAL, LLC
Model
CP-10A
Device description
Tape
Published
2024-10-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EXMTruss, Umbilical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EXMTruss, UmbilicalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10840277405798PackageGS112In Commercial Distribution
00840277405791PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084027740579810840277405798
00840277405791008402774057918402774057910840277405791

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord tapeA thin, flat strip of synthetic and/or natural material which is used as a tie or suture around the umbilical cord of a newborn infant after severance from the placenta. It typically consists of a braided strip of cotton thread and or spun polyester yarn and comes in a variety of sizes. This is a single-use device.

Regulatory Flags#

DUNS number
964053560
Device count
1
Premarket exempt
true
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
00840277412010ApeTapeP63-21B-2040-012026-05-22
00840277412027ApeTapeP63-21W-2040-012026-05-22
00840277404992OsseoFit™ Subscapularis Kit (Suture Anchor)1200020502024-12-31
00840277405005OsseoFit™ Subscapularis Kit (Bone Tunnel)1200020512024-12-31
00840277401380Fracture Repair Suture Kit1100464562022-11-04
00840277401403Open Soft Tissue Repair Suture Kit-Small3910-900-1452022-11-04
00840277401410Open Soft Tissue Repair Suture Kit-Large3910-900-1462022-11-04
00840277401373MaxBraid Suture BroadBand Tape (Basic)1100466022022-07-27
00840277401397MaxBraid Suture BroadBand Tape (Ultra)1100464552022-07-27
00840277411105Native Root500.0002026-05-06
00840277411112Native Root501.0002026-05-06
00840277412034No-Tie Button101.0002026-05-06
00810020082982HS FiberHS2312020-03-04
00810020082999HS FiberHS2322020-03-04
00812444026726HS SUTURE TAPEHS2092017-07-19
00812444026757HS SUTURE TAPEHS2112017-07-19
00810020083491HS FiberHS3392026-04-23
00840277411433SutUpHS156-MU2026-04-14
00840277411440SutUpHS519-MU2026-04-14
00840277411457SutUpHS1062-MU2026-04-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840277405807Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00840277405814Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405798Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405804Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405811Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00810113576541ViveVIVE HEALTH LLCEXM2024-05-03
10810113576548ViveVIVE HEALTH LLCEXM2024-05-03
10790986000008CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2024-03-29
00790986000001CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2024-03-29
10790986000558CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
10790986000565CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
00790986000551CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
00790986000568CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24
20790986000555CP Cotton Umbilical TapeC.P. MEDICAL CORPORATIONEXM2015-09-24