FDA.reportPublic FDA data

Medline

Primary DI
40080196029755
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
SPT-2208CS
Catalog number
SPT-2208CS
Device description
GOWN POLY W/BREATH SLEEVES XL
Published
2016-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FYAGOWN, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FYAGown, SurgicalGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
40080196029755PackageGS1100In Commercial Distribution
10080196029754PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
4008019602975540080196029755
1008019602975410080196029754

GMDN Terms#

Term, Definition table
TermDefinition
Surgical gown, single-useA garment made of natural and/or synthetic materials intended to be worn over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
100
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809518442430SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442447SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442454SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
08809518442461SEJONG Surgical Gown SoftSejong Healthcare Co, Ltd.FYA2026-05-07
09009607822207ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822214ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607822221ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832206ViVi TOGA Premium Size XL-XXLTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832213ViVi TOGA Premium Size M-LTHI Total Healthcare Innovation GmbHFYA2025-06-13
09009607832220ViVi TOGA Premium Size XXS-STHI Total Healthcare Innovation GmbHFYA2025-06-13
07613327625196Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625219Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625226Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625240Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625257Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625264Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625271Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625288Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625295Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625301Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625318Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625325Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625332Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625349Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625356Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625363Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625370Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625387Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625394Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21
07613327625400Steri-ShieldSTRYKER CORPORATIONFYA2025-02-21