FDA.report

ADC®

Primary DI
00634782801786
Brand
ADC®
Company
AMERICAN DIAGNOSTIC CORP
Model
3656
Catalog number
3656
Device description
Umbilical Cord Scissors,4"
Published
2016-09-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
LRWScissors, General, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
LRWScissors, General, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00634782801786PackageGS112In Commercial Distribution
00634782001797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00634782801786006347828017866347828017860634782801786
00634782001797006347820017976347820017970634782001797

GMDN Terms

TermDefinition
Umbilical cord scissors, reusableA hand-held manual surgical instrument designed specifically to cut the umbilical cord after birth. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is metallic and is available in various designs and sizes; the blades can have a variety of sizes and designs, e.g., curved, acutely angled at the tip, or have flat opposing moon shapes, and may be serrated. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
1-800-232-2670info@adctoday.com

Regulatory Flags

DUNS number
108999095
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
true

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