FDA.reportPublic FDA data

SDP Inc.

Primary DI
10810124990005
Brand
SDP Inc.
Company
Sdp Inc. Specialite De Produits Dermatologiques
Model
SDP-21818S
Device description
COTTON TAPE UMBILICAL
Published
2023-07-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

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
10810124990005PackageGS120In Commercial Distribution
00810124990008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081012499000510810124990005
00810124990008008101249900088101249900080810124990008

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
258686179
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
false
Expiration date on label
false
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
00810124990008SDP Inc.SDP-21818S2023-07-06

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
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
00749756138468DeRoyalDEROYAL INDUSTRIES, INC.FOD2021-07-12