FDA.reportPublic FDA data

Paul Banditt

Primary DI
D955TISAB1X21
Brand
Paul Banditt
Company
Terlain Enterprises, Inc.
Model
TISAB1X2
Device description
PAUL BANDITT AB1X2 ADSON BROWN TISSUE FORCEP, 1X2 TEETH, 12cm
Published
2023-12-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
D955TISAB1X21PrimaryHIBCC0

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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
177465051
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D95516CASS1Paul Banditt16CASS2026-09-25
D9555CASS1Paul Banditt5CASS2026-09-25
D9558CASS1Paul Banditt8CASS2026-09-25
D955BBCG35450Paul BandittBBCG35452026-09-25
D955BBGA351Paul BandittBBGA352026-09-25
D955BBGA451Paul BandittBBGA452026-09-25
D955BBGA551Paul BandittBBGA552026-09-25
D955BBGA701Paul BandittBBGA702026-09-25
D955BDT11Paul BandittBDT12026-09-25
D955BDT21Paul BandittBDT22026-09-25
D955BDT31Paul BandittBDT32026-09-25
D955BDT61Paul BandittBDT62026-09-25
D955BDT71Paul BandittBDT72026-09-25
D955BDT81Paul BandittBDT82026-09-25
D955BDT91Paul BandittBDT92026-09-25
D955BLAHST1Paul BandittBLAHST2026-09-25
D955BMDG010Paul BandittBMDG-012026-09-25
D955BMDG021Paul BandittBMDG-022026-09-25
D955BMDG031Paul BandittBMDG-032026-09-25
D955BONDNG1Paul BandittBONDNG2026-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B382SD9025181000Surgical DirectSurgical Direct, Inc.EFL2026-08-07
B382S2752108T0Surgical DirectSurgical Direct, Inc.EFL2026-08-03
B382S25681060Surgical DirectSurgical Direct, Inc.EFL2026-07-29
B382SD37103120Surgical DirectSurgical Direct, Inc.EFL2026-07-28
B382SD914817010Surgical DirectSurgical Direct, Inc.EFL2026-07-28
00190776400279MillenniumAvalign Technologies, Inc.EFL2026-07-17
00850083275525Intrace USAPILOTIS TECH LLCEFL2026-07-03
05060212051264College Dental Forceps 160mmDTR MEDICAL LIMITEDEFL2026-06-10
B382S28531030Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S28531040Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S2853252T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382S285401100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902172106T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9023191000Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9027351020Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531080Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531260Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531290Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028531720Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541100Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD9028541170Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902861100T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902869400Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902870110Surgical DirectSurgical Direct, Inc.EFL2026-06-08
B382SD902991101T0Surgical DirectSurgical Direct, Inc.EFL2026-06-08
G149TBSB7960TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7970TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149TBSB7980TBS BASICSACME ENTERPRISE.EFL2026-05-22
G149NP380750NPSACME ENTERPRISE.EFL2026-05-01
G149NPRMF0NPSACME ENTERPRISE.EFL2026-05-01