FDA.report

ELMED

Primary DI
00842180119192
Brand
ELMED
Company
ELMED INCORPORATED
Model
E174CM6
Catalog number
E174CM6
Device description
MEDIUM BLUE TITANIUM HEMOSTATIC CLIPS (20 CARTRIDGES OF 6 PER BOX), STERILE
Published
2018-04-04
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
FZPClip, Implantable
HCFInstrument, Ligature Passing And Knot Tying

Product Code Classifications

CodeDeviceSpecialtyClass
FZPClip, ImplantableGeneral, Plastic Surgery2
HCFInstrument, Ligature Passing And Knot TyingGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180119192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180119192008421801191928421801191920842180119192

GMDN Terms

TermDefinition
Scalp clip forcepsA hand-held, manually-operated, surgical instrument used to manually apply and remove haemostatic scalp clips (reusable or single-use) from the scalp during or after a surgical intervention on the cranium/scalp. It is typically a scissors-like device with ring handles, and may or may not be self-retaining. The working end of the device will typically have dedicated grasping blades that are profiled/designed to accommodate a compatible scalp clip. The device is available in various sizes and is typically made of high-grade stainless steel. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
224-353-6446medical@elmed.com

Regulatory Flags

DUNS number
049290364
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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