FDA.reportPublic FDA data

Precept®

Primary DI
20814707021084
Brand
Precept®
Company
PRECEPT MEDICAL PRODUCTS, INC.
Model
35 2502
Device description
Protective Sleeve
Published
2018-09-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20814707021084PrimaryGS10
00814707021080Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081470702108420814707021084
00814707021080008147070210808147070210800814707021080

GMDN Terms#

Term, Definition table
TermDefinition
Surgical sleeve cover, non-sterileA non-sterile forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-438-5827customerservice@preceptmed.com

Regulatory Flags#

DUNS number
783912892
Device count
200
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10814707020585Precept®65 33952016-08-05
10814707020592Precept®65 3395S2016-08-05
10814707020998Precept®10112018-09-18
10814707021032Precept®52002018-09-18
10814707021964Precept®221412018-09-18
10814707021971Precept®221512018-09-18
10814707021988Precept®220102018-09-18
10814707021995Precept®220202018-09-18
10814707022008Precept®220302018-09-18
10814707022015Precept®220322018-09-18
10814707022022Precept®221112018-09-18
10814707022039Precept®221212018-09-18
10814707022046Precept®221312018-09-18
10814707022862Precept®10142018-09-18
20814707020995Precept®10112018-09-18
10814707021001Precept®22102018-09-18
20814707021039Precept®52002018-09-18
20814707021961Precept®221412018-09-18
20814707021978Precept®221512018-09-18
20814707021985Precept®220102018-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10097604245002Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245057Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245101Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245200Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245309Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245354Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245408Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245453Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245507Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604245552Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956007Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956052Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956106Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956205Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956304Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956359Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956403Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956458Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956502Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10097604956557Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2024-08-12
10195327657802Medline Industries, Inc.MEDLINE INDUSTRIES, INC.LYU2024-07-29
10097604245064Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245163Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245262Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245361Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245460Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245569Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245668Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245767Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28
10097604245866Tronex International, Inc.TRONEX INTERNATIONAL, INC.LYU2023-08-28