FDA.report

ELMED

Primary DI
00842180109308
Brand
ELMED
Company
ELMED INCORPORATED
Model
52605-39A
Catalog number
52605-39A
Device description
5MM DIA., 33 CM, FENESTRATED GRASPER 22 MM, STRAIGHT SERRATED JAWS W/ LONG FENESTRATION FOR ATRAUMATIC GRIP, DOUBLE-ACTION, INSULATED SHAFT, SLIDE-LOCK HANDLE, RIGID ONE-PIECE (A)
Published
2017-08-23
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
NWVLaparoscopic Accessories, Gynecologic

Product Code Classifications

CodeDeviceSpecialtyClass
NWVLaparoscopic Accessories, GynecologicObstetrics/Gynecology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842180109308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842180109308008421801093088421801093080842180109308

GMDN Terms

TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. 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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