FDA.report

MEDLINE

Primary DI
20193489112693
Brand
MEDLINE
Company
MEDLINE INDUSTRIES, INC.
Model
67335
Catalog number
67335
Device description
DISP.UMBILICAL CORD CLAMP CUTTER(CTR300)
Published
2021-11-12
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

Related Records

Contact Domains

Product Codes

CodeName
KOHINSTRUMENT, MANUAL, GENERAL OBSTETRIC-GYNECOLOGIC

Product Code Classifications

CodeDeviceSpecialtyClass
KOHInstrument, Manual, General Obstetric-GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489112693PackageGS150In Commercial Distribution
10193489112696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2019348911269320193489112693
1019348911269610193489112696

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463CUSTOMERSERVICE@MEDLINE.COM

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
true
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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