FDA.reportPublic FDA data

Tronex International, Inc.

Primary DI
00097604429429
Brand
Tronex International, Inc.
Company
TRONEX INTERNATIONAL, INC.
Model
4294B
Device description
Cap, Surgeon, Multilayer, Fluid Resistant, Latex-Free, Blue, Unisize
Published
2022-10-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FYFCap, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYFCap, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10097604429426PrimaryGS10
00097604429429Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1009760442942610097604429426
00097604429429000976044294290976044294290097604429429

GMDN Terms#

Term, Definition table
TermDefinition
Surgical cap, single-useA head covering designed as a cap intended to be worn by surgical staff during an operation to protect both the patient and themselves from the transfer of microorganisms, body fluids, and particulate material; it may also be used as a hygienic head covering in other healthcare settings. It is usually made of reinforced paper or non-woven materials. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
615425519
Device count
500
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00097604555517Tronex International, Inc.5555W2025-07-28
00097604577021Tronex International, Inc.577025W2025-07-24
00097604577045Tronex International, Inc.577035W2025-07-24
00097604130585Tronex International, Inc.TCB0305C2025-05-01
00097604140584Tronex International, Inc.TCB0405C2025-05-01
00097604160582Tronex International, Inc.TCB0605C2025-05-01
00097604220583Tronex International, Inc.TLB2205L2025-05-01
00097604330589Tronex International, Inc.TLB3305L2025-05-01
00097604440585Tronex International, Inc.TLB4405L2025-05-01
00097604660587Tronex International, Inc.TLB6605L2025-05-01
00097604015561Tronex International, Inc.TCB0155R2025-01-28
00097604010580Tronex International, Inc.TCB0105C2024-12-30
00097604020589Tronex International, Inc.TCB0205C2024-12-30
00097604110587Tronex International, Inc.TCB1105A2024-12-30
00097604120586Tronex International, Inc.TCB1205A2024-12-30
00097604212199Tronex International, Inc.SD21212024-12-30
00097604215190Tronex International, Inc.SD21512024-12-30
00097604313193Tronex International, Inc.SD31312024-12-30
00097604422291Tronex International, Inc.TCB4222N2024-12-30
00097604423397Tronex International, Inc.TCB4233N2024-12-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
30197344202212MEDLINEMEDLINE INDUSTRIES, INC.FYF2026-03-16
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06979032640086GOBENHUZHOU JUNDA INDUSTRY CO., LTD.FYF2025-08-26
10813360021519ProtexerICP MEDICAL, LLCFYF2025-08-19
00810184641346GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641353GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641360GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641377GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184641384GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00810184642442GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859211GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859877GCB Medical SupplyGCB MEDICAL LLCFYF2025-07-24
00850061859129GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
00850061859143GCB Medical Supply NovaplusGCB MEDICAL LLCFYF2025-07-23
10827989003641Health Care Logistics, Inc®Health Care Logistics, Inc.FYF2025-04-22
TQ26126151700Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126151990Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
TQ26126152000Top Quality ManufacturingTOP QUALITY MANUFACTURING, INC.FYF2024-12-09
20810141933235VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933242VIVIT SupplyVivit Supply LLCFYF2024-11-29
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20810141933266VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933273VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933280VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933297VIVIT SupplyVivit Supply LLCFYF2024-11-29
20810141933303VIVIT SupplyVivit Supply LLCFYF2024-11-29
14719882252522CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252546CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252560CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06
14719882252584CopioumedCOPIOUMED INTERNATIONAL INC.FYF2024-11-06