FDA.reportPublic FDA data

Encompass

Primary DI
10612899005560
Brand
Encompass
Company
Encompass Group, L.L.C.
Model
G-P9163A
Device description
EVOLUTION PATIENT PANT, L,60EA TS EVO PATIENT PANT, ELAST/NO BINDING, GREEN, SBPP, 60 EA/CS
Published
2023-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10612899005560PackageGS160In Commercial Distribution
20612899005567PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1061289900556010612899005560
2061289900556720612899005567

GMDN Terms#

Term, Definition table
TermDefinition
Patient gown, single-useA non-sterile garment made of natural and/or synthetic materials (e.g., paper, cloth, plastic) intended to be worn by patients in a clinical setting (e.g., during hospitalization, during examination in a doctor's office). A patient gown is usually short-sleeved and may be closed by ties at the back/side of the garment. This is a single-use garment.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-284-4540compliance@encompassgroup.net

Regulatory Flags#

DUNS number
121788819
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00612899045484EncompassVA550-252023-06-22
00612899101104EncompassVA550-25XB2023-06-22
20612899002726EncompassTP1002023-06-22
20612899004713EncompassG-P91532023-06-22
20612899004720EncompassG-P9163A2023-06-22
20612899005574EncompassG-P91642023-06-22
20612899005581EncompassG-P9165A2023-06-22
20612899005598EncompassG-P91662023-06-22
20612899005604EncompassG-P91512023-06-22
20612899005611EncompassG-P91522023-06-22
20612899005628EncompassG-P91542023-06-22
20612899005635EncompassG-P91552023-06-22
20612899005642EncompassG-P91562023-06-22
20612899005659EncompassG-P9161A2023-06-22
20612899005666EncompassG-P9162A2023-06-22
20612899005673EncompassG-P91642023-06-22
20612899005680EncompassP9165A2023-06-22
20612899005697EncompassP91662023-06-22
20612899005826EncompassG-P91502023-06-22
20612899005864EncompassG-P91602023-06-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842942017537PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
00842942007828PRIMEDpriMED Medical Products IncFME2025-07-21
00842942008207PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009341PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009358PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009365PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009372PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009556PRIMEDpriMED Medical Products IncFME2025-07-21
00842942009563PRIMEDpriMED Medical Products IncFME2025-07-21
00842942013928PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014475PRIMEDpriMED Medical Products IncFME2025-07-21
00842942014482PRIMEDpriMED Medical Products IncFME2025-07-21
00842942016080PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524410PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524441PRIMEDpriMED Medical Products IncFME2025-07-15
10097604573327Tronex International, Inc.TRONEX INTERNATIONAL, INC.FME2024-12-30
10850053289511SURGYCOSurgyco LLCFME2024-08-09
10850053289559SURGYCOSurgyco LLCFME2024-08-09
10850053289566SURGYCOSurgyco LLCFME2024-08-09
10850053289573SURGYCOSurgyco LLCFME2024-08-09
10850053289740SURGYCOSurgyco LLCFME2024-08-09
10850053289757SURGYCOSurgyco LLCFME2024-08-09
10810141931388VIVIT SupplyVivit Supply LLCFME2024-01-19
10810141931395VIVIT SupplyVivit Supply LLCFME2024-01-19
10850045738065UNCThe University of North Carolina Health SystemFME2023-10-31
10810141930473VIVIT SupplyVivit Supply LLCFME2023-09-15
10810141930480VIVIT SupplyVivit Supply LLCFME2023-09-15