FDA.reportPublic FDA data

Umbilical Tape

Primary DI
10840277405798
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
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
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.

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
00840277407962JuggerKnotless® Soft Anchor1200039652025-10-13
00840277407979JuggerKnotless® Soft Anchor1200039662025-10-13
00840277407986JuggerKnotless® Soft Anchor1200039672025-10-13
00840277407993JuggerLoop™ Soft Anchor1200039682025-10-13
00840277408006JuggerLoop™ Soft Anchor1200039692025-10-13
00840277408013JuggerLoop™ Soft Anchor1200039702025-10-13
00840277408020JuggerLoop™ Soft Anchor1200039712025-10-13
00840277407955JuggerKnotless Soft Anchor1200039642025-07-29
00840277405012OC JuggerKnotless® Soft Anchor1200039562024-12-19
00840277405029OC JuggerKnotless® Soft Anchor1200039572024-12-19
00840277405036OC JuggerKnotless® Soft Anchor1200039582024-12-19
00840277405043OC JuggerKnotless® Soft Anchor1200039592024-12-19
00840277405050OC JuggerLoop™ Soft Anchor1200039602024-12-19
00840277405067OC JuggerLoop™ Soft Anchor1200039612024-12-19
00840277405074OC JuggerLoop™ Soft Anchor1200039622024-12-19
00840277405081OC JuggerLoop™ Soft Anchor SP1200039632024-12-19
00840277411815Gold MarkerGM0453-20202026-03-11
00812444022056RIVERPOINT BRACHYTHERAPYGM1031-18202015-10-22
00812444022070RIVERPOINT BRACHYTHERAPYGM1033-18202015-10-22
00812444022124RIVERPOINT BRACHYTHERAPYGM1053-18202015-10-22

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
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