FDA.reportPublic FDA data

BLUE AND GREEN

Primary DI
00840018648869
Brand
BLUE AND GREEN
Company
NORDENT MANUFACTURING INC
Model
CVCALL1/BG
Device description
B&G CARVER LOMA LIND #1
Published
2020-07-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EKHCarver, Dental Amalgam, Operative

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKHCarver, Dental Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840018648869PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840018648869008400186488698400186488690840018648869

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Sterilization Methods#

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

Regulatory Flags#

DUNS number
053187985
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
00840018674646SabraNAB2/6Nordent Diagnostic Cataloge2026-05-12
00840018674653Nordent Manufacturing, Inc. TCNSGRA13-14Nordent Hygiene Catalogue2026-05-12
00840018674622Nordent Manufacturing, Inc. BUR2892Nordent Restorative Catalouge2026-05-05
00840018674639Nordent Manufacturing, Inc. RFPH9-10Nordent Surgical Catalog2026-05-05
00008418674554Nordent Manufacturing, Inc. OPPLN3-4Nordent Hygiene Catalogue2026-04-10
00840018674578Nordent Manufacturing, Inc. CENSN128Nordent Hygiene Catalogue2026-04-10
00840018674585Nordent Manufacturing, Inc. SGR17-18/BG6Nordent Hygiene Catalogue2026-04-10
00840018674592Nordent Manufacturing, Inc. N113/BG6Nordent Restorative Catalouge2026-04-10
00840018674608Nordent Manufacturing, Inc. SCA204-4Nordent Hygiene Catalogue2026-04-10
00840018674530Nordent Manufacturing, Inc. TCNSN137Nordent Hygiene Catalogue2026-03-14
00840018674547Nordent Manufacturing, Inc. OPPLN1-2Nordent Hygiene Catalogue2026-03-14
00840018674554Nordent Manufacturing, Inc. oppln3-4Nordent Hygiene Catalogue2026-03-14
00840018674561Nordent Manufacturing, Inc. OPPLN5-6Nordent Hygiene Catalogue2026-03-14
00840018674417Nordent Manufacturing, Inc. OPGN2Nordent Hygiene Catalogue2026-03-12
00840018674424Nordent Manufacturing, Inc. OPGN4Nordent Hygiene Catalogue2026-03-12
00840018674431Nordent Manufacturing, Inc. OPGN5-48Nordent Hygiene Catalogue2026-03-12
00840018674455Nordent Manufacturing, Inc. OPGNE128-128Nordent Hygiene Catalogue2026-03-12
00840018674462Nordent Manufacturing, Inc. OPGNMJNordent Hygiene Catalogue2026-03-12
00840018674479Nordent Manufacturing, Inc. OPGNMJTNordent Hygiene Catalogue2026-03-12
00840018674493Nordent Manufacturing, Inc. OPPM17S-18SNordent Hygiene Catalogue2026-03-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G8791024510DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024520DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G879102453H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024540DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G879102455H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G8791024570DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKH2026-08-22
G149TBSB4090TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4100TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4110TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4120TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4130TBS BASICSACME ENTERPRISE.EKH2026-05-20
G149TBSB4280TBS BASICSACME ENTERPRISE.EKH2026-05-20
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10889950005474HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
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10889950005498HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12
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10889950006914HU-FRIEDYHU-FRIEDY MFG. CO., LLCEKH2020-11-12