FDA.report

ELMED

Primary DI
00842180107601
Brand
ELMED
Company
ELMED INCORPORATED
Model
52255-68C
Catalog number
52255-68C
Device description
5MM DIA., 33CM, BIOPSY SPOON FORCEPS, W/ TOOTH (SEMM-TYPE), DBL-ACTION- INSULATED SHAFT & HANDLE W/ RF-POST, MODULAR 3-PIECE SCREW-APART
Published
2017-04-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180107601PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180107601008421801076018421801076010842180107601

GMDN Terms

TermDefinition
Biopsy punch, reusableA manual surgical instrument designed to obtain a tissue or bone sample typically for histopathological analysis. The instrument may be ring-handled, pistol grip, or shaft-like in design. Ring-handled or pistol grip designs feature extended shafts which terminate in a punch-like or mechanical jaw mechanism at the distal tip. The shaft-like instrument is a hollow tube, sharpened on one end, and is usually used with a trocar. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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