FDA.reportPublic FDA data

DENSOL

Primary DI
G879103062TC0
Brand
DENSOL
Company
DENSOL INTERNATIONAL (PRIVATE) LIMITED
Model
103-062TC
Catalog number
103-062TC
Device description
Kelly Scissors TC 16cm Straight
Published
2026-09-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EGNScissors, Surgical Tissue, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGNScissors, Surgical Tissue, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G879103062TC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental surgical scissorsA hand-held dental instrument used to cut oral tissue during a dental surgical procedure. It comprises two pivoted blades that are usually provided with a finger and thumb ring-handle and which cut with a shearing action (i.e., the blades cut as the sharpened edges pass one another as they are closed). It is typically made of high-grade stainless steel and has blades that terminate in sharp, fine, points. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
775322952
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G879100044A0DENSOL100-044A100-044A2026-09-30
G879100049A0DENSOL100-049A100-049A2026-09-30
G8791028230DENSOL102-823102-8232026-09-30
G879103050TC0DENSOL103-050TC103-050TC2026-09-30
G879103052SC0DENSOL103-052SC103-052SC2026-09-30
G8791030560DENSOL103-056103-0562026-09-30
G8791030620DENSOL103-062103-0622026-09-30
G8791030650DENSOL103-065103-0652026-09-30
G879103065TC0DENSOL103-065TC103-065TC2026-09-30
G8791030680DENSOL103-068103-0682026-09-30
G8791030740DENSOL103-074103-0742026-09-30
G8791030750DENSOL103-075103-0752026-09-30
G8791030760DENSOL103-076103-0762026-09-30
G8791030770DENSOL103-077103-0772026-09-30
G8791030780DENSOL103-078103-0782026-09-30
G8791030900DENSOL103-090103-0902026-09-30
G8791030910DENSOL103-091103-0912026-09-30
G8791030920DENSOL103-092103-0922026-09-30
G8791030930DENSOL103-093103-0932026-09-30
G8791030950DENSOL103-095103-0952026-09-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879103050TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103052SC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030560DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030620DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030650DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103065TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030680DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030740DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030750DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030760DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030770DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030780DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030900DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030910DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030920DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030930DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030950DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791030960DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103107TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031120DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103113TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103116TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879103118TC0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031220DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G8791031230DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
G879GTC130DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-09-30
B382SD903260120Surgical DirectSurgical Direct, Inc.EGN2026-09-29
G8791030490DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEGN2026-08-23
B382SD9032161050Surgical DirectSurgical Direct, Inc.EGN2026-08-07