FDA.report

American Eagle Instruments

Primary DI
00841013112997
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AEWPKT1
Published
2022-05-23
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
true

Related Records

Product Codes

CodeName
EIYINSTRUMENT, FILLING, PLASTIC, DENTAL

Product Code Classifications

CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841013112997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013112997008410131129978410131129970841013112997

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

Regulatory Flags

DUNS number
790776850
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
false
Sterilization required before use
false

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00841013120640Otto LeibingerAESRLAN12026-01-06

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00840018661639Nordent Manufacturing, Inc. NORDENT MANUFACTURING INCEIY2026-01-28
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