FDA.reportPublic FDA data

Precept®

Primary DI
20814707021077
Brand
Precept®
Company
PRECEPT MEDICAL PRODUCTS, INC.
Model
8571
Device description
Cysto Apron
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
20814707021077PrimaryGS10
00814707021073Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081470702107720814707021077
00814707021073008147070210738147070210730814707021073

GMDN Terms#

Term, Definition table
TermDefinition
Hygiene apron, single-useA non-sterile garment designed to be worn by healthcare staff for general protection from soiling or spills on the ventral (front) aspect of the body, and typically to prevent penetration of infectious material, during the course of work or a procedure. It is typically made of a thin plastic polymer. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8004385827customerservice@preceptmed.com

Regulatory Flags#

DUNS number
783912892
Device count
20
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
00749756401753DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401760DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401777DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00749756401784DeRoyalDEROYAL INDUSTRIES, INC.LYU2026-09-18
00850078013101MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013118MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013125MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013132MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00850078013149MAXAIRSyntech, Int'l Inc.LYU2026-08-26
00840456224571JMUJMU DENTAL, INCLYU2026-08-18
00840456224588JMUJMU DENTAL, INCLYU2026-08-18
00840456224595JMUJMU DENTAL, INCLYU2026-08-18
00840456224601JMUJMU DENTAL, INCLYU2026-08-18
00840456224618JMUJMU DENTAL, INCLYU2026-08-18
00840456218402JMUJMU DENTAL, INCLYU2026-07-06
00840456218419JMUJMU DENTAL, INCLYU2026-07-06
00840456218426JMUJMU DENTAL, INCLYU2026-07-06
00840456218433JMUJMU DENTAL, INCLYU2026-07-06
00840456218440JMUJMU DENTAL, INCLYU2026-07-06
00840456218457JMUJMU DENTAL, INCLYU2026-07-06
00840456218464JMUJMU DENTAL, INCLYU2026-07-06
00840456218471JMUJMU DENTAL, INCLYU2026-07-06
00840456218488JMUJMU DENTAL, INCLYU2026-07-06
00840456218495JMUJMU DENTAL, INCLYU2026-07-06
00840456220894JMUJMU DENTAL, INCLYU2026-07-06
00840456220900JMUJMU DENTAL, INCLYU2026-07-06
00840456220917JMUJMU DENTAL, INCLYU2026-07-06
00840456220924JMUJMU DENTAL, INCLYU2026-07-06
00840456220931JMUJMU DENTAL, INCLYU2026-07-06
00840456220948JMUJMU DENTAL, INCLYU2026-07-06