FDA.report

SURGYCO

Primary DI
00850044799558
Brand
SURGYCO
Company
Surgyco LLC
Model
PS010380
Device description
Surgyco Disposable Bouffant Cap SPP Blue, 21"
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

Related Records

Product Codes

CodeName
LYUAccessory, Surgical Apparel

Product Code Classifications

CodeDeviceSpecialtyClass
LYUAccessory, Surgical ApparelGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850044799555PrimaryGS10
00850044799558Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004479955510850044799555
00850044799558008500447995588500447995580850044799558

GMDN Terms

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

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 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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