FDA.reportPublic FDA data

J & J INSTRUMENTS

Primary DI
00817524026955
Brand
J & J INSTRUMENTS
Company
J & J INSTRUMENTS INC
Model
35-1245
Device description
"TISSUE FCP 4.5"""" 1x2 "
Published
2019-11-06
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
00817524026955PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817524026955008175240269558175240269550817524026955

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. 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
783328149
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817524029963J&J Instruments03-50003-5002023-10-10
00817524029970J&J Instruments09-50009-5002023-10-10
00817524027846J&J Instruments42-123042-12302023-03-01
00817524027853J&J Instruments42-127042-12702023-03-01
00817524022865J&J Instruments07-2002019-10-07
00817524020328J & J INSTRUMENTS02-010 02-010 2018-05-31
00817524020335J & J INSTRUMENTS02-02002-0202018-05-31
00817524020359J & J INSTRUMENTS02-10102-1012018-05-31
00817524020397J & J INSTRUMENTS02-275 02-275 2018-05-31
00817524020403J & J INSTRUMENTS02-28502-2852018-05-31
00817524020410J & J INSTRUMENTS02-28602-2862018-05-31
00817524020427J & J INSTRUMENTS02-28702-2872018-05-31
00817524020434J & J INSTRUMENTS02-28802-2882018-05-31
00817524020441J & J INSTRUMENTS02-29102-2912018-05-31
00817524020458J&J Instruments02-292 02-292 2018-10-16
00817524020465J&J Instruments02-293 02-293 2018-10-16
00817524020472J&J Instruments02-294 02-294 2018-10-16
00817524020489J&J Instruments02-295 02-295 2018-10-16
00817524020496J&J Instruments02-296 02-296 2018-10-16
00817524020618J & J INSTRUMENTS INC02-50002-5002018-10-17

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
G149NP380750NPSACME ENTERPRISE.EFL2026-05-01
G149NPRMF0NPSACME ENTERPRISE.EFL2026-05-01
00371347023503Advance Dental ProductsThe Atlanta Dental Supply CompanyEFL2026-04-14
ESAM3851141STOMA®Storz am Mark GmbHEFL2026-03-25
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
B382S8531000Surgical DirectSurgical Direct, Inc.EFL2026-02-12
B382SD6525000Surgical DirectSurgical Direct, Inc.EFL2026-02-12
B382SD9028701240Surgical DirectSurgical Direct, Inc.EFL2026-02-12
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