FDA.reportPublic FDA data

Exam Capes, Tissue/Poly/Tissue 3-ply, White, Universal

Primary DI
00616784811130
Brand
Exam Capes, Tissue/Poly/Tissue 3-ply, White, Universal
Company
Dynarex Corporation
Model
8111
Published
2021-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
00616784811130PrimaryGS10
00810180846929Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784811130006167848111306167848111300616784811130
00810180846929008101808469298101808469290810180846929

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.

Regulatory Flags#

DUNS number
008124539
Device count
100
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
true
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
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08
00616784418520Bandage Shears 7.5" (19.1 cm) Red41852020-11-08
00616784418629Bandage Shears 7.5" (19.1 cm) Teal41862020-11-08
00616784418728Bandage Shears 7.5" (19.1 cm) Yellow41872020-11-08
00616784419022Mini Scissors 4" (10.2 cm) Red41902020-11-08
00616784419121Bandage Shears 5.5" (14.0 cm) Black41912020-11-08
00616784419220Bandage Shears 5.5" (14.0 cm) Blue41922020-11-08
00616784419329Bandage Shears 5.5" (14.0 cm) Magenta41932020-11-08
00616784419428Bandage Shears, 5.5" (14.0 cm) Orange41942020-11-08
00616784419527Bandage Shears 5.5" (14.0 cm) Purple41952020-11-08
00616784419626Bandage Shears, 5.5" (14.0 cm) Red41962020-11-08
00616784419725Bandage Shears, 5.5" (14.0 cm) Teal41972020-11-08
00616784419824Bandage Shears,5.5" (14.0 cm) Yellow41982020-11-08
00616784711522PA SensiLance Pressure Activated Safety Lancets,Sterile71152021-05-21
00616784711621Disposable Ear Specula Tips, For Diagnostic Otoscopes, 2.5 mm, Pediatric71162021-05-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16975803530881GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
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
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10810141930237VIVIT SupplyVivit Supply LLCFME2023-09-10
10810141930244VIVIT SupplyVivit Supply LLCFME2023-09-10
10850044799890SURGYCOSurgyco LLCFME2023-06-30
10850044799906SURGYCOSurgyco LLCFME2023-06-30
10850044799913SURGYCOSurgyco LLCFME2023-06-30
10850044799937SURGYCOSurgyco LLCFME2023-06-30
10850044799944SURGYCOSurgyco LLCFME2023-06-30
20612899005482EncompassEncompass Group, L.L.C.FME2023-06-21
20612899005499EncompassEncompass Group, L.L.C.FME2023-06-21