FDA.report

AESCULAP

Primary DI
04038653147885
Brand
AESCULAP
Company
Aesculap AG
Model
DE443R
Catalog number
DE443R
Device description
CONDENSER ROUND F.MICROENDODONTIA
Published
2020-06-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
EKGCONDENSER, AMALGAM AND FOIL, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKGCondenser, Amalgam And Foil, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04038653147885PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04038653147885040386531478854038653147885

GMDN Terms

TermDefinition
Dental spatula, reusableA hand-held manual dental device used to manipulate filling materials in the plastic state. It is typically made of stainless steel with a small, flat, blunt blade (no sharp edges) at one end, or it may be double-ended. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags

DUNS number
315018218
Device count
1
DM exempt
true
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 DIBrandModelCatalogPublished
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17
04038653038282AESCULAPDP540RDP540R2020-06-17
04038653038299AESCULAPDP541RDP541R2020-06-17
04038653038305AESCULAPDP542RDP542R2020-06-17
04038653177011AESCULAPOG961ROG961R2016-09-23
04038653251407AESCULAPOG960ROG960R2016-09-23
04038653044207MIASPAS MINI-ALIFFF569RFF569R2020-06-17
04038653044214MIASPAS MINI-ALIFFF571RFF571R2020-06-17
04038653044252MIASPAS MINI-ALIFFF578RFF578R2020-06-17
04038653044283MIASPAS MINI-ALIFFF586RFF586R2020-06-17
04038653117307AESCULAPNH196NH1962017-01-27
04038653117352AESCULAPNH206NH2062017-01-27
04038653118540AESCULAPNK088NK0882015-11-11
04038653118557AESCULAPNK089NK0892015-09-24
04038653118564AESCULAPNK090NK0902015-09-24

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00840018671867Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018671904Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-10
00840018666092Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-02-09
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00840018663275Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-29
00840018661325Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661387Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661769Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
00840018661936Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKG2026-01-28
05010058178106InstrapacROBINSON HEALTHCARE LIMITEDEKG2025-06-23
00889813065976Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKG2024-12-12
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08800075604668OSUNG MNDOSUNG MND Co., Ltd.EKG2024-03-04
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