FDA.reportPublic FDA data

American Eagle Instruments

Primary DI
00841013104015
Brand
American Eagle Instruments
Company
AMERICAN EAGLE INSTRUMENTS, INC.
Model
AECP1CFSM
Catalog number
AECP1CFSM
Device description
BELVEDERE P1-CF (SM) CONT FORM
Published
2022-07-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIYInstrument, Filling, Plastic, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIYInstrument, Filling, Plastic, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841013104015PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841013104015008410131040158410131040150841013104015

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (800) 551 5172customerservice@am-eagle.com

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
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841013108297American Eagle InstrumentsAEHA10-10OA2022-05-23
00841013108303American Eagle InstrumentsAEHA10-112022-05-23
00841013108310American Eagle InstrumentsAEHA11-11OA2022-05-23
00841013108358American Eagle InstrumentsAEHA17-182022-05-23
00841013108365American Eagle InstrumentsAEHA8-8OA2022-05-23
00841013108372American Eagle InstrumentsAEHA8-92022-05-23
00841013109621American Eagle InstrumentsAEPEM92022-05-23
00841013124648MicroquoreAESNHMACS2026-06-26
00841013124655MicroquoreAESNHBAC2026-06-26
00841013124686MicroquoreAESMSNH2026-06-26
00841013124693MicroquoreAESMSSTT2026-06-26
00841013124709MicroquoreAESMSTCO2026-06-26
00841013124716MicroquoreAESMSSSM2026-06-26
00841013124723MicroquoreAESMSSTD2026-06-26
00841013124761American Eagle InstrumentsAEC1/4DINAEC1/4DIN 2026-02-12
00841013124778American Eagle InstrumentsAEC1/2DINAEC1/2DIN2026-02-12
00841013124785American Eagle InstrumentsAESCDINAESCDIN2026-02-12
00841013124792American Eagle InstrumentsAESCCONAESCCON2026-02-12
00841013124808American Eagle InstrumentsAECAGRAILAECAGRAIL2026-02-12
00841013124815American Eagle InstrumentsAECRAILAECRAIL2026-02-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB4010TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4020TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4030TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4040TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4050TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4060TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4070TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4080TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4140TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4150TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4200TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4210TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB4220TBS BASICSACME ENTERPRISE.EIY2026-05-20
G149TBSB8130TBS BASICSACME ENTERPRISE.EIY2026-05-18
G149TBSB8010TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8020TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8030TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149TBSB8040TBS BASICSACME ENTERPRISE.EIY2026-05-17
G149NPBPT0NPSACME ENTERPRISE.EIY2026-05-01
08800075626134OSUNG MNDOSUNG MND Co., Ltd.EIY2025-11-03
07649988072451OdneFill TipOdne AGEIY2024-02-01
00841013108297American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EIY2022-05-23
00841013108303American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EIY2022-05-23
00841013108310American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EIY2022-05-23
00841013108358American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EIY2022-05-23
00841013108365American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EIY2022-05-23
00841013108372American Eagle InstrumentsAMERICAN EAGLE INSTRUMENTS, INC.EIY2022-05-23
10889950005283HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005290HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12
10889950005306HU-FRIEDYHU-FRIEDY MFG. CO., LLCEIY2020-11-12