FDA.report

OSSEOUS Tilley's Nasal Dressings Forceps

Primary DI
08906039318067
Brand
OSSEOUS Tilley's Nasal Dressings Forceps
Company
EON MEDITECH PRIVATE LIMITED
Model
EI06
Device description
It is used to perform anterior nasal packing, To remove foreign bodies, crusts or packs for the nose, To pack the nose with gauze stripe during nasal surgeries or sinus surgeries. To remove cartilage and bone pieces during septoplasty or SMR.
Published
2024-07-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KAEForceps, Ent

Product Code Classifications

CodeDeviceSpecialtyClass
KAEForceps, EntEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08906039318067PackageGS11In Commercial Distribution
08906039316049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08906039318067089060393180678906039318067
08906039316049089060393160498906039316049

GMDN Terms

TermDefinition
Dressing/utility forceps, scissors-like, reusableA hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius25 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
930270428
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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