FDA.report

SURGYCO

Primary DI
00850044799633
Brand
SURGYCO
Company
Surgyco LLC
Model
PS010150XXL
Device description
Surgyco Disposable Scrub Shirt SMS-Blue, XX-Large
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
FXOSuit, Surgical

Product Code Classifications

CodeDeviceSpecialtyClass
FXOSuit, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10850044799630PrimaryGS10
00850044799633Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1085004479963010850044799630
00850044799633008500447996338500447996330850044799633

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
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
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10889813060176Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060183Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
10889813060190Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCFXO2023-08-30
06921340881118customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340882115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340883112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340884119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06921340885116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340881115customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340882112customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340883119customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340884116customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
16921340885113customizedQingdao Bestex Rubber & Plastic Products Co., Ltd.FXO2023-06-16
06973635612013MaoshengXianTao Maosheng Plastic Products Co., LtdFXO2023-03-31
00850044799596SURGYCOSurgyco LLCFXO2023-02-16
00850044799602SURGYCOSurgyco LLCFXO2023-02-16
00850044799619SURGYCOSurgyco LLCFXO2023-02-16
00850044799626SURGYCOSurgyco LLCFXO2023-02-16
00850044799640SURGYCOSurgyco LLCFXO2023-02-16
00850044799657SURGYCOSurgyco LLCFXO2023-02-16
00850044799664SURGYCOSurgyco LLCFXO2023-02-16
00850044799671SURGYCOSurgyco LLCFXO2023-02-16
00850044799688SURGYCOSurgyco LLCFXO2023-02-16
16975257180502TSWXiantao TSW Protective Products Co.,LtdFXO2023-02-16
00097604440127Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440226Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440325Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440424Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440523Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28
00097604440622Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXO2022-10-28