FDA.report

ELMED

Primary DI
00198506003776
Brand
ELMED
Company
ELMED INCORPORATED
Model
ST3261025IT
Catalog number
ST3261025IT
Device description
INSULATED SCHRODER TENACULUM SINGLE TOOTH FORCEP BRAUN STYLE FLAT TIP 10" INSULATED TIP 10"
Published
2024-04-25
Public version status
New
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
HCZForceps, Surgical, Gynecological

Product Code Classifications

CodeDeviceSpecialtyClass
HCZForceps, Surgical, GynecologicalObstetrics/Gynecology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00198506003776PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00198506003776001985060037761985060037760198506003776

GMDN Terms

TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

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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