FDA.reportPublic FDA data

DeRoyal

Primary DI
00749756026246
Brand
DeRoyal
Company
DEROYAL INDUSTRIES, INC.
Model
31-041
Catalog number
31-041
Device description
CORD CLAMP
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
50749756026241PackageGS150In Commercial Distribution
00749756026246PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5074975602624150749756026241
00749756026246007497560262467497560262460749756026246

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord clamp, single-useA sterile, hand-held manual surgical instrument designed to temporarily compress the umbilical cord immediately after birth. It is used before cutting or ligating (e.g., with a clip) the cord, and is intended to enable aseptic haemostasis. It is typically made of plastic material and may incorporate features such as serrations on the contact area and/or a security lock. 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