FDA.reportPublic FDA data

umbili-GRIP

Primary DI
00852568002152
Brand
umbili-GRIP
Company
Divergent Medical Technologies LLc
Model
A01
Catalog number
CLW-2004-A01
Device description
Umbili-GRIP traditional style (Hollister) clamp - sterile, un-numbered, crème color, single use. Box of 100 clamps.
Published
2024-07-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
00852568002152PrimaryGS10
00852568002190Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852568002152008525680021528525680021520852568002152
00852568002190008525680021908525680021900852568002190

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(201)644-0844support@divergentmedical.com

Regulatory Flags#

DUNS number
024385611
Device count
100
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00852568002138umbili-CLAMPA01CLW-1004-A012024-07-18
00852568002176umbili-CUTTERA01CLW-1007-A012024-07-18
00852568002169umbili-CLAMPA01CLW-1004-A012024-07-18
00852568002190umbili-GRIPA01CLW-2004-A012024-07-18
00852568002183umbili-CUTTERA01CLW-1007-A012024-07-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00852568002138umbili-CLAMPDivergent 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
00749756138468DeRoyalDEROYAL INDUSTRIES, INC.FOD2021-07-12