FDA.reportPublic FDA data

American Medicals

Primary DI
B35644051815A0
Brand
American Medicals
Company
American Medicals
Model
1
Published
2022-09-10
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

Product Codes#

Code, Name table
CodeName
EFLForceps, Dressing, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFLForceps, Dressing, DentalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B35644051815A0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, tweezers-like, reusableA hand-held, manual, open-surgery instrument designed to facilitate grasping and manipulation of soft-tissues. It has a tweezers-like design (may be a micro/fine instrument) with variously designed tips at the working end, whereby the blades are designed to be opened/closed by squeezing between the fingers (i.e., without ring handles). It is made of high-grade stainless steel, available in various sizes, and may have carbide inserts at the working end. It is not an electrosurgical device and not dedicated to ophthalmic surgery. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Microwave Radiation

Regulatory Flags#

DUNS number
109909627
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
B356JD259280American Medicals12026-03-09
B356JB543320American Medicals12026-02-26
B356JB641170American Medicals12026-02-06
B356DF370170American Medicals12026-01-30
B356BK905180American Medicals12026-01-27
B356FH454070American Medical12025-12-10
B356FH455060American Medicals12025-12-10
B356ED107160American Medicals12025-12-03
B356JB536280American Medicals12025-11-25
B356KD932040American Medicals12025-09-18
B356KD932070American Medicals12025-09-18
B356KE334280American Medicals12025-09-15
B356KJ522130American Medicals12025-09-12
B356FF131030American Medicals12025-08-16
B356FF131050American Medicals12025-08-16
B356KE292350American Medicals12025-08-15
B356KE295040American Medicals12025-08-15
B356KE296030American Medicals12025-08-15
B356KE312070American Medicals12025-08-15
B356KE328060American Medicals12025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G149TBSB7960TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7970TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7980TBS BASICSACME ENTERPRISE.EFL2026-05-22
B382S2511200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548010Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2548020Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382S2871200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9025111020Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9027671000Surgical DirectSurgical Direct, Inc.EFL2026-03-09
B382SD9029931200Surgical DirectSurgical Direct, Inc.EFL2026-03-09
G1493807407TBS DentalACME ENTERPRISE.EFL2026-03-02
G1493807508TBS DentalACME ENTERPRISE.EFL2026-03-02
B382S349601020Surgical DirectSurgical Direct, Inc.EFL2026-02-10
B382SD902544180Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9025471040Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD90260200Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028531460Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532000Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028532510Surgical DirectSurgical Direct, Inc.EFL2026-02-04
B382SD9028541010Surgical DirectSurgical Direct, Inc.EFL2026-02-04
00841013120718Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120725Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120732Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120749Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120756Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120763Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120770Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120787Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120794Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06
00841013120800Otto LeibingerAMERICAN EAGLE INSTRUMENTS, INC.EFL2026-01-06