FDA.report

SCHWERT

Primary DI
E8962619100
Brand
SCHWERT
Company
A. Schweickhardt GmbH & Co. KG
Model
2619-10
Catalog number
2619-10
Device description
Medicine bowl 0,02l
Published
2023-02-22
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

Related Records

Contact Domains

Product Codes

CodeName
EHKCUP, PROPHYLAXIS

Product Code Classifications

CodeDeviceSpecialtyClass
EHKCup, ProphylaxisDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
E8962619100PrimaryHIBCC0

GMDN Terms

TermDefinition
General-purpose bowl, reusableA portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+49746498910700contact@schwert.com

Regulatory Flags

DUNS number
341195628
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
true
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
E89628870SCHWERT288728872025-12-16
E89617059007E0SCHWERT1705-90-07E1705-90-07E2025-09-04
E89617059101E0SCHWERT1705-91-01E1705-91-01E2025-09-04
E89617059206E0SCHWERT1705-92-06E1705-92-06E2025-09-04
E89617059303E0SCHWERT1705-93-03E1705-93-03E2025-09-04
E896294760SCHWERT29476294762025-06-10
E896294980SCHWERT29498294982025-06-10
E8964320SCHWERT4324322025-06-10
E896169520SCHWERT1695-21695-22025-05-19
E8965000260SCHWERT5000-265000-262025-04-08
E8965000270SCHWERT5000-275000-272025-04-08
E8965000280SCHWERT5000-285000-282025-04-08
E8965000540SCHWERT5000-545000-542025-04-08
E8961033610SCHWERT1033-611033-612025-04-07
E8961137170SCHWERT1137-171137-172025-04-07
E8961411040SCHWERT1411-041411-042025-04-07
E8961411060SCHWERT1411-061411-062025-04-07
E896169710007E0SCHWERT1697-100-07E1697-100-07E2025-04-07
E89616971TI06E0SCHWERT1697-1TI-06E1697-1TI-06E2025-04-07
E896170512007E0SCHWERT1705-120-07E1705-120-07E2025-04-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850079280366CavexHexa DentalEHK2026-01-22
00850079280373CavexHexa DentalEHK2026-01-22
00850079280380CavexHexa DentalEHK2026-01-22
00883205032638OpalCupsULTRADENT PRODUCTS, INC.EHK2025-03-11
06975492100023PBCDONGGUAN YILONG MEDICAL SUPPLIES CO.. LTD.EHK2025-01-09
TQ26PA25523S0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
TQ26PA25525F0Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.EHK2024-10-31
10302730003243Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003250Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003267Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
10302730003274Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003284Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00302730003291Young DentalYOUNG DENTAL MANUFACTURING I, LLCEHK2024-09-27
00842517111578Karl SchumacherKarl Schumacher Dental, LLCEHK2024-03-01
00842517103214Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00842517103221Karl SchumacherKarl Schumacher Dental, LLCEHK2024-02-27
00348783001181ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00348783004564ProFlarePREMIER DENTAL PRODUCTS COMPANYEHK2023-10-26
00813360023424AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023431AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023448AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023455AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023462AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023479AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023486AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023493AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023509AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023516AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023523AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25
00813360023530AllProTEAM TECHNOLOGIES, INC.EHK2023-07-25