FDA.reportPublic FDA data

CUP

Primary DI
00888118069559
Brand
CUP
Company
KLS-Martin L.P.
Model
44-200-31-01
Published
2018-09-26
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EKICARRIER, AMALGAM, OPERATIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKICarrier, Amalgam, OperativeDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888118069559PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888118069559008881180695598881180695590888118069559

GMDN Terms#

Term, Definition table
TermDefinition
Dental amalgam carrierA hand-held dental instrument specially designed to collect, transport and deposit amalgam in its plastic state into prepared cavities. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(904)641-7746KLS-UDI-Info@klsmartin.com

Regulatory Flags#

DUNS number
826499238
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888118131782LEVEL ONE EXTREMITY26-066-60-092026-05-25
00888118131799LEVEL ONE EXTREMITY26-066-70-092026-05-25
00888118144928LEVEL ONE EXTREMITY26-950-40-072026-05-25
00888118145284PURE PECTUS24-070-60-092026-05-25
00888118145291PURE PECTUS24-070-62-092026-05-25
00888118150240PURE PECTUSCTM-241-100-012026-05-25
00888118150257PURE PECTUSCTM-241-101-012026-05-25
00888118150264PURE PECTUSCTM-241-200-012026-05-25
00888118150448IXOSCTM-263-100-012026-05-25
00888118150455IXOSCTM-263-101-012026-05-25
00888118150462IXOSCTM-263-202-012026-05-25
00888118150479IXOSCTM-263-202-022026-05-25
00888118150486IXOSCTM-263-202-032026-05-25
00888118150493IXOSCTM-263-202-042026-05-25
00888118150646IPS60-011-42-09-LP2026-05-25
00888118153029L1 STERNALCTM-242-302-012026-05-25
00888118153050IXOSCTM-263-203-012026-05-25
00888118153067IXOSCTM-263-203-022026-05-25
00888118153074IXOSCTM-263-203-032026-05-25
00888118153081IXOSCTM-263-203-042026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB8180TBS BASICSACME ENTERPRISE.EKI2026-05-18
G149TBSB8190TBS BASICSACME ENTERPRISE.EKI2026-05-18
00371347023428Advance Dental ProductsThe Atlanta Dental Supply CompanyEKI2026-04-14
00348783008753Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-18
00348783008760Premier Amalgam CarrierPREMIER DENTAL PRODUCTS COMPANYEKI2026-03-17
08800075627698OSUNG MNDOSUNG MND Co., Ltd.EKI2025-11-03
07898078650134SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078657423SPEED GUNAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
07898078659427EdgeUtopia RRM Dispensing GunAngelus Industria de Produtos Odontologicos S AEKI2025-03-20
00813677023063PDT, Inc.PDT, INC.EKI2024-07-02
00813677023087PDT, Inc.PDT, INC.EKI2024-07-02
00813677023070PDT, Inc.PDT, INC.EKI2024-07-01
00813677023124PDT, Inc.PDT, INC.EKI2024-06-27
00813677024978PDT, Inc.PDT, INC.EKI2024-06-27
00840105223160ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223177ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223184ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223191ZOLL DENTALZoll-DentalEKI2024-05-31
00840105223207ZOLL DENTALZoll-DentalEKI2024-05-31
D105SKU1312510SurgiMac Surgimac LLCEKI2024-05-08
D105SKU131257H02SurgiMac Surgimac LLCEKI2024-04-22
D105SKU131257H13SurgiMac Surgimac LLCEKI2024-04-22
10889950142407Amalgam Carrier, Reg/MiniHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142414Amalgam Carrier, Reg/LrgHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142421Amalgam Carrier, Reg/JumboHU-FRIEDY MFG. CO., LLCEKI2024-04-02
10889950142438Amalgam WellHU-FRIEDY MFG. CO., LLCEKI2024-04-02
D105SKU1312550SurgiMac Surgimac LLCEKI2024-03-18
D105SKU1312551SurgiMac Surgimac LLCEKI2024-03-18
08800075626325OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-23
08800075603531OSUNG MNDOSUNG MND Co., Ltd.EKI2024-02-21