FDA.reportPublic FDA data

Umbilical Tape

Primary DI
10840277405804
Brand
Umbilical Tape
Company
RIVERPOINT MEDICAL, LLC
Model
CP-11A
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
Rx
false
OTC
false
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
10840277405804PackageGS112In Commercial Distribution
00840277405807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084027740580410840277405804
00840277405807008402774058078402774058070840277405807

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964053560
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
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
00840277405791Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00840277405807Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
00840277405814Umbilical TapeRIVERPOINT MEDICAL, LLCEXM2024-10-08
10840277405798Umbilical 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