FDA.reportPublic FDA data

SURGYCO

Primary DI
00850044799572
Brand
SURGYCO
Company
Surgyco LLC
Model
PS010400
Device description
Surgyco Disposable Surgeons Cap SMS-Blue Universal Size
Published
2023-02-16
Public version status
New
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
FYFCap, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044799579PrimaryGS10
00850044799572Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004479957910850044799579
00850044799572008500447995728500447995720850044799572

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose syringe, single-useA sterile device consisting of a calibrated barrel (cylinder) with plunger intended to be used for injection/withdrawal of fluids/gas (e.g., medication) to/from a medical device or the body (i.e., capable of both); a needle is not included. It is intended for various medical applications and is not dedicated to medication administration. At the distal end of the barrel is a male connector (typically Luer-lock/slip type) for the attachment to a hypodermic needle or an administration set. It is typically made of plastic and silicone materials and may have anti-stick plunger allowing smooth plunger movement, either manually or by a syringe pump. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
118768538
Device count
1000
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20850074089067Surgyco010-VPSB21G22025-12-23
20850074089074Surgyco010-VPSB23G22025-12-23
20850074089081Surgyco010-VPSB25G22025-12-23
20850074089098Surgyco010-VPB23G22025-12-23
20850074089104Surgyco010-VPN01102025-12-23
20850074089111Surgyco010-VPN01202025-12-23
20850053289679SurgycoSEN102302025-12-11
20850053289877SURGYCOSSNG00102025-07-11
20850053289884SURGYCOSSNG00152025-07-11
20850053289891SURGYCOSSNG00202025-07-11
20850074089012JDL Sensitive010-12502025-07-11
20850074089029JDL Sensitive010-12602025-07-11
20850074089036JDL Sensitive010-12702025-07-11
20850074089043JDL Sensitive010-12802025-07-11
00850053289729SURGYCOPS011730L2024-08-30
00850053289736SURGYCOPS011730XL2024-08-30
20850053289785SURGYCORS0905602024-08-30
00850049784986SURGYCORS0908002024-08-09
00850053289507SURGYCOPS0104452024-08-09
00850053289514SURGYCOPSS102852024-08-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
20810141933259VIVIT SupplyVivit Supply LLCFYF2024-11-29
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