FDA.reportPublic FDA data

SURGYCO

Primary DI
00850044799909
Brand
SURGYCO
Company
Surgyco LLC
Model
PSS10210
Device description
Surgyco Disposable Exam Gowns Blue 3 Ply T/P/T Universal Size
Published
2023-06-30
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
FMEGown, Examination

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMEGown, ExaminationGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850044799906PrimaryGS10
00850044799909Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004479990610850044799906
00850044799909008500447999098500447999090850044799909

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
50
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
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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26975803530888GSOGroup Supply Organization Medical Technology(Shanghai) LtdFME2025-11-30
10842942017527PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
10842942017534PRIMED / CaracalpriMED Medical Products IncFME2025-11-26
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10842942009553PRIMEDpriMED Medical Products IncFME2025-07-21
10842942009560PRIMEDpriMED Medical Products IncFME2025-07-21
10842942013925PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014472PRIMEDpriMED Medical Products IncFME2025-07-21
10842942014489PRIMEDpriMED Medical Products IncFME2025-07-21
10842942016087PRIMEDpriMED Medical Products IncFME2025-07-21
05391534524427PRIMEDpriMED Medical Products IncFME2025-07-21
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00840456201572JMUJMU DENTAL, INCFME2025-07-15
00840456201589JMUJMU DENTAL, INCFME2025-07-15
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00840456201602JMUJMU DENTAL, INCFME2025-07-15
00840456201619JMUJMU DENTAL, INCFME2025-07-15
00840456201626JMUJMU DENTAL, INCFME2025-07-15
00840456201633JMUJMU DENTAL, INCFME2025-07-15
00840456201640JMUJMU DENTAL, INCFME2025-07-15
00840456201657JMUJMU DENTAL, INCFME2025-07-15
00840456201664JMUJMU DENTAL, INCFME2025-07-15
00840456201671JMUJMU DENTAL, INCFME2025-07-15