Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cm

Primary DI
10815288014345
Brand
Round Tip Allis Grasping Forcep, Ratcheting Handle, With Rotation, 35cm
Company
ENCISION, INC.
Model
EP3100RR
Catalog number
EP3100RR
Published
2024-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HETLaparoscope, Gynecologic (And Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K925079000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K925079000LAPAROSCOPIC INST. (SCISSORS,FORCEPS,NEEDLEHOLDER)Endo Technic Corp.1994-08-24HET

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815288014345PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081528801434510815288014345

GMDN Terms#

Term, Definition table
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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Centimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
612250175
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

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