FDA.report

American Medicals

Primary DI
B356111OPPL211ST1
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
true
Single use
true

Related Records

Product Codes

CodeName
GENForceps, General & Plastic Surgery

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B356111OPPL211ST1PackageHIBCC25In Commercial Distribution
B356111OPPL211ST0PrimaryHIBCC0

GMDN Terms

TermDefinition
Ophthalmic soft-tissue manipulation forceps, tweezers-like, single-useA sterile, hand-held manual surgical instrument designed to facilitate grasping, manipulation or clamping of, and/or removal of foreign bodies from, ophthalmic soft-tissues (ocular tissues, eyelids), and may be pointed for capsulorhexis. It has a conventional (self-opening) or reverse-action (self-closing) tweezers-like design, 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 not probe-like in design (i.e., not cannulated). It is typically made of metal, available in various sizes, and may have carbide inserts at the working end. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
109909627
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
true
Sterilization required before use
false

Other Devices From This Company

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 DIBrandCompanyProduct codePublished
00190776417925MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776417963MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418045MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418052MillenniumAvalign Technologies, Inc.GEN2026-03-23
24026704941555PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941562PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941579PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941609PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
00192896122949Deluxe Alligator Grasping ForcepsSONTEC INSTRUMENTS, INC.GEN2026-03-19
04046826492632MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
04046826492649MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
G453FA06160PEAK MEDICALPeak Medical Distribution Inc.GEN2026-03-19
00190776417703MillenniumAvalign Technologies, Inc.GEN2026-03-11
00190776417819MillenniumAvalign Technologies, Inc.GEN2026-03-11
00840329836924Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GEN2026-03-05
04058749036152NAFehling Instruments GmbH & Co. KGGEN2026-03-05
00198506088667ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088674ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088872ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00198506088742ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00190776416713MillenniumAvalign Technologies, Inc.GEN2026-02-20
00810130207350MSIModern Surgical Instruments LLCGEN2026-02-20
B382SD6720680Surgical DirectSurgical Direct, Inc.GEN2026-02-17
B382SD6720690Surgical DirectSurgical Direct, Inc.GEN2026-02-17
00190776416508MillenniumAvalign Technologies, Inc.GEN2026-02-16
B382SD49129280Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6522210Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6536480Surgical DirectSurgical Direct, Inc.GEN2026-02-16
03662663129046Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCGEN2026-02-11