FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756023771
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
30-410
Catalog number
30-410
Device description
Twill Tape, Cotton
Published
2021-06-30
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
FODDEVICE, OCCLUSION, UMBILICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FODDevice, Occlusion, UmbilicalGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50749756023776PackageGS1100In Commercial Distribution
00749756023771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602377650749756023776
00749756023771007497560237717497560237710749756023771

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.

Contacts#

Phone, Email table
PhoneEmail
+1(888)938-7828udisupport@deroyal.com

Regulatory Flags#

DUNS number
096372255
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00749756402316DeRoyalNP-6006ULNP-6006UL2026-10-16
00749756402323DeRoyalNP-6007ULNP-6007UL2026-10-16
00749756402330DeRoyalNP-6008ULNP-6008UL2026-10-16
00749756402347DeRoyalNP-0080ULNP-0080UL2026-10-16
00749756402354DeRoyalNP-6014ULNP-6014UL2026-10-16
00749756402361DeRoyalNP-6015ULNP-6015UL2026-10-16
00749756402378DeRoyalNP-6016ULNP-6016UL2026-10-16
00749756402989DeRoyalNP-0250UNP-0250U2026-09-30
00749756402996DeRoyalNP-0450UNP-0450U2026-09-30
00749756403009DeRoyalNP-0450UNNP-0450UN2026-09-30
00749756403016DeRoyalNP-0250UNNP-0250UN2026-09-30
00749756403023DeRoyalNP-0250U-01NP-0250U-012026-09-30
00749756403375DeRoyal31-120P31-120P2026-09-30
00749756369640DeRoyalNP-7000NP-70002026-09-23
00749756389181DeRoyal81-1020SU81-1020SU2026-09-21
00749756389204DeRoyal81-1020REF81-1020REF2026-09-21
00749756399258DeRoyal46-326XBNS46-326XBNS2026-09-21
00749756400442DeRoyal77-40111877-4011182026-09-21
00749756985475DeRoyalNP-790NP-7902026-09-21
00749756985963DeRoyalNP-7300-01NP-7300-012026-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852568002138umbili-CLAMPDivergent Medical Technologies LLcFOD2024-07-18
00852568002152umbili-GRIPDivergent Medical Technologies LLcFOD2024-07-18
00852568002169umbili-CLAMPDivergent Medical Technologies LLcFOD2024-07-18
00852568002190umbili-GRIPDivergent Medical Technologies LLcFOD2024-07-18
00630094064246Bioseal Inc.BIOSEALFOD2024-01-29
00630094064369Bioseal Inc.BIOSEALFOD2024-01-29
00630094064918Bioseal Inc.BIOSEALFOD2024-01-29
00630094068121Bioseal Inc.BIOSEALFOD2024-01-29
00630094068244Bioseal Inc.BIOSEALFOD2024-01-29
00630094068367Bioseal Inc.BIOSEALFOD2024-01-29
00630094068824Bioseal Inc.BIOSEALFOD2024-01-29
00630094680095Bioseal Inc.BIOSEALFOD2024-01-29
10630094064243Bioseal Inc.BIOSEALFOD2024-01-29
10630094064366Bioseal Inc.BIOSEALFOD2024-01-29
10630094064915Bioseal Inc.BIOSEALFOD2024-01-29
10630094068128Bioseal Inc.BIOSEALFOD2024-01-29
10630094068241Bioseal Inc.BIOSEALFOD2024-01-29
10630094068364Bioseal Inc.BIOSEALFOD2024-01-29
10630094068821Bioseal Inc.BIOSEALFOD2024-01-29
10630094680092Bioseal Inc.BIOSEALFOD2024-01-29
00810124990008SDP Inc.Sdp Inc. Specialite De Produits DermatologiquesFOD2023-07-06
10810124990005SDP Inc.Sdp Inc. Specialite De Produits DermatologiquesFOD2023-07-06
10888277804708Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FOD2022-08-04
40888277804709Medline Industries, Inc.MEDLINE INDUSTRIES, INC.FOD2022-08-04
00840216105003ASP MEDICALAsp Global, LLCFOD2022-07-29
00840216105010ASP MEDICALAsp Global, LLCFOD2022-07-29
M75257015210STRADIS HEALTHCARESTRADIS MEDICAL, LLCFOD2022-04-06
M75257015220STRADIS HEALTHCARESTRADIS MEDICAL, LLCFOD2022-04-06
M75257015200STRADIS HEALTHCARESTRADIS MEDICAL, LLCFOD2022-03-02
00749756138451DeRoyalDEROYAL INDUSTRIES, INC.FOD2021-07-12