FDA.reportPublic FDA data

Precept®

Primary DI
20814707020810
Brand
Precept®
Company
PRECEPT MEDICAL PRODUCTS, INC.
Model
51192B
Device description
Over-the-Head Thumb Loop Gown with Elastic Wrists - Open Back
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20814707020810PrimaryGS10
00814707020816Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081470702081020814707020810
00814707020816008147070208168147070208160814707020816

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
783912892
Device count
100
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
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00842942017506PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
00842942017513PRIMED / CaracalpriMED Medical Products IncOEA2025-11-26
10097604577028Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
10097604577042Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2025-07-24
00842942015700PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942015717PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017261PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942017278PRIMEDpriMED Medical Products IncOEA2025-07-17
00842942007934PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942008047PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009570PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942009587PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014406PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942014420PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015298PRIMEDpriMED Medical Products IncOEA2025-07-15
00842942015427PRIMEDpriMED Medical Products IncOEA2025-07-15
20885380151511CARDINAL HEALTHCARDINAL HEALTH 200, LLCOEA2025-03-22
10197106720950CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106720974CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721032CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106721056CARDINAL HEALTHCardinal Health 200, LLCOEA2024-11-15
10197106741979CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-11
10197106472408CARDINAL HEALTHCardinal Health 200, LLCOEA2024-10-07
10197106743669CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-26
10197106743256CARDINAL HEALTHCardinal Health 200, LLCOEA2024-09-20
10097604466407Tronex International, Inc.TRONEX INTERNATIONAL, INC.OEA2024-09-16
10193489099560MEDLINEMEDLINE INDUSTRIES, INC.OEA2024-07-04
10197106675250CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-27
10197106665183CARDINAL HEALTHCardinal Health 200, LLCOEA2024-06-25