FDA.reportPublic FDA data

umbili-CUTTER

Primary DI
00852568002176
Brand
umbili-CUTTER
Company
Divergent Medical Technologies LLc
Model
A01
Catalog number
CLW-1007-A01
Device description
Clamp Cutter - Disposable umbilical cord clamp cutter, sterile, Tyvek pouch, Yellow, SUD. Box of 50 cutters
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
JOKSCISSORS, MEDICAL, DISPOSABLE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JOKScissors, Medical, DisposableGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852568002176PrimaryGS10
00852568002183Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852568002176008525680021768525680021760852568002176
00852568002183008525680021838525680021830852568002183

GMDN Terms#

Term, Definition table
TermDefinition
Umbilical cord clamp/cutterA sterile, hand-held manual surgical instrument designed with a clamping and cutting mechanism to simultaneously clamp and sever the umbilical cord immediately after birth. It may be used on the maternal side of the umbilical cord and on the infant side, typically where the clamp remains until the cord stub falls off. It is typically made of plastic materials [e.g., polycarbonate (PC)]. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+1(201)644-0844support@divergentmedical.com

Regulatory Flags#

DUNS number
024385611
Device count
50
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
00852568002152umbili-GRIPA01CLW-2004-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
04059453062727Hermann Medizintechnik GmbHHermann Medizintechnik GmbHJOK2026-02-24
04059453062765Hermann Medizintechnik GmbHHermann Medizintechnik GmbHJOK2025-09-09
00653160385397MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-21
10653160385547MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
10653160386155MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
00653160385540MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
00653160386158MEDLINEMEDLINE INDUSTRIES, INC.JOK2025-02-11
20197344102584MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102591MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102607MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102621MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102638MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102645MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344117984MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102581MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102598MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102604MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102628MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102635MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344102642MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
30197344117981MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-31
20197344102614MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-25
30197344102611MEDLINEMEDLINE INDUSTRIES, INC.JOK2024-10-25
05708932556569ColoplastColoplast A/SJOK2024-08-23
05708932556576ColoplastColoplast A/SJOK2024-08-23
00193489139870CURADMEDLINE INDUSTRIES, INC.JOK2024-08-22
10193489139877CURADMEDLINE INDUSTRIES, INC.JOK2024-08-22
10195327656249Medline Industries, Inc.MEDLINE INDUSTRIES, INC.JOK2024-07-29
40195327656240Medline Industries, Inc.MEDLINE INDUSTRIES, INC.JOK2024-07-29
00852568002183umbili-CUTTERDivergent Medical Technologies LLcJOK2024-07-18