FDA.report

Brasseler USA

Primary DI
00887919683605
Brand
Brasseler USA
Company
Peter Brasseler Holdings, LLC
Model
5023574U0
Device description
EXC14 EXCAV REG #4 HDL 1P
Published
2022-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
EKCEXCAVATOR, DENTAL, OPERATIVE

Product Code Classifications

CodeDeviceSpecialtyClass
EKCExcavator, Dental, OperativeDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887919683605PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887919683605008879196836058879196836050887919683605

GMDN Terms

TermDefinition
Dental excavator, reusableA hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
082080136
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
true
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

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Other Devices Sharing Product Codes

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00840018674219Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-11
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00840018666511Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-09
00840018666979Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-02-09
00840018662575Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEKC2026-01-29
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05010058178113InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
05010058182691InstrapacROBINSON HEALTHCARE LIMITEDEKC2025-06-23
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00889813065402Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEKC2024-12-18
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00813677024503PDT, Inc.PDT, INC.EKC2024-06-27
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