FDA UDI In Commercial Distribution 🇺🇸 United States

Hartmann Cup Forceps 3mm/9cm

DI: G25010092120 · Model: 10-092-12 · N S SURGICAL COMPANY
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

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Basic Information

Brand Name
Hartmann Cup Forceps 3mm/9cm
Primary DI
G25010092120
Version / Model
10-092-12
Catalog Number
10-092-12
Company Name
N S SURGICAL COMPANY
Labeler DUNS
645681649
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2023-04-29
Public Version
1
Public Version Date
2023-05-08
Public Version Status
New
Public Device Record Key
f39314ac-e672-4594-8efc-a38810e2659e

Device Description

A long, thin, hand-held manual surgical instrument designed to facilitate grasping and manipulation of soft-tissues/anatomical structures [typically during ear/nose/throat (ENT) surgery]; it is not intended for insertion through an endoscope, nor into the eye, and is not a dedicated biopsy device. Commonly referred to as alligator- or crocodile-forceps, it has a slender body (to allow for restricted access) and small grasping blades which are hinged close to the distal (working) end. It is a metallic device available in various sizes/lengths; some types may include an integrated suction channel. This is a reusable device intended to be sterilized prior to use.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
No
Has Lot/Batch Number
Yes
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
Yes
Sterilization Methods
Ultraviolet Light, Ethylene Oxide, Moist Heat or Steam Sterilization

Product Codes

Code Name
KAE Forceps, Ent

GMDN Terms

Code Name
62467 Surgical soft-tissue manipulation forceps, alligator, reusable

Identifiers

Type ID
Primary G25010092120

Device Sizes

Type Value Unit Text
Length 9 Centimeter
Device Size Text, specify Cup Size 3mm