FDA.reportPublic FDA data

Nivo

Primary DI
08964003163273
Brand
Nivo
Company
B. Ali Impex
Model
NRDCFI
Device description
Rubber Dam Clamp Forceps, 1vory Type
Published
2024-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
EJGForceps, Rubber Dam Clamp

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EJGForceps, Rubber Dam ClampDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08964003163273PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08964003163273089640031632738964003163273

GMDN Terms#

Term, Definition table
TermDefinition
Rubber dam clamp forcepsA hand-held dental instrument used for the insertion and removal of rubber dam clamps. It is typically designed with permanently joined handles pivoted scissor-like, and has small projections at the working end that fit into corresponding holes in the rubber dam clamp. It will typically have a sliding lock mechanism that locks the handles in position while the operator moves the rubber dam clamp around the tooth. This is a reusable device.

Sterilization Methods#

Method table
Method
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"
Ethylene Oxide;Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
645802117
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08964003163853Doctor Nice786-28L102024-01-29
08964003163860Doctor Nice786-30L102024-01-29
08964003163877Doctor Nice786-04G32024-01-29
08964003163884Doctor Nice786-04L2024-01-29
08964003163891Doctor Nice786-03L2024-01-29
08964003163075Doctor Nice786-14786-142023-11-10
08964003163112Doctor Nice786-14G42023-11-10
08964003163129Doctor Nice786-33G22023-11-10
08964003163136Doctor Nice786-34G22023-11-10
08964003163143Doctor Nice786-14G52023-11-10
08964003163020Doctor Nice786-012023-11-09
08964003163037Doctor Nice786-022023-11-09
08964003163051Doctor Nice786-032023-11-09
08964003163068Doctor Nice786-152023-11-09
08964003163082Doctor Nice786-15/G22023-11-09
08964003163099Doctor Nice786-14/G22023-11-09
08964003163105Doctor Nice786-15G42023-11-09
08964003163150Doctor Nice786-04LB2023-11-09
08964003163167Doctor Nice786-282023-11-09
08964003163174Doctor Nice786-302023-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB2110TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2120TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2130TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2150TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2160TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2170TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2180TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2190TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2200TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2210TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2220TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2230TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2240TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2250TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2260TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2270TBS BASICSACME ENTERPRISE.EJG2026-05-16
G149TBSB2280TBS BASICSACME ENTERPRISE.EJG2026-05-16
00371347023534Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
00371347023541Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
00371347023558Advance Dental ProductsThe Atlanta Dental Supply CompanyEJG2026-04-14
08800019151012BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151029BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151036BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151043BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151050BL Clamp B& L Biotech, inc.EJG2025-07-18
08800019151067BL Clamp B& L Biotech, inc.EJG2025-07-18
07899798207721QuinelatoSchobell Industrial LtdaEJG2025-02-27
00889813063583Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEJG2024-11-30
00348783001488Premier Rubber Dam PunchPREMIER DENTAL PRODUCTS COMPANYEJG2024-08-01
00813677023315PDT, Inc.PDT, INC.EJG2024-06-27