FDA.reportPublic FDA data

StringKing

Primary DI
10195376201858
Brand
StringKing
Company
String King Lacrosse LLC
Model
DIG.SMS.L2.XL.BLU
Device description
Disposable Isolation Gown, AAMI Level 2, SMS, Blue, X-Large
Published
2022-07-18
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
OEANon-Surgical Isolation Gown

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OEANon-Surgical GownGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10195376201858PackageGS138In Commercial Distribution
20195376201855PackageGS110In Commercial Distribution
30195376201852PackageGS110In Commercial Distribution
00195376201851PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1019537620185810195376201858
2019537620185520195376201855
3019537620185230195376201852
00195376201851001953762018511953762018510195376201851

GMDN Terms#

Term, Definition table
TermDefinition
Isolation gown, single-useA garment made of natural and/or synthetic materials intended to be worn by healthcare providers or visitors to isolate themselves from patients. The isolation gown helps to protect the patient (e.g., burn patients) from the transfer of infectious agents carried by the healthcare provider or visitor; or it may help to protect the healthcare provider or visitor from a contagious agent which has infected the patient. This is a single-use garment.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
065807495
Device count
1
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
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195376201844StringKingDIG.SMS.L2.L.BLU2022-07-18
00195376201851StringKingDIG.SMS.L2.XL.BLU2022-07-18
10195376202121StringKing20212DSG.SMS.L3.S.BLU2021-08-03
10195376202145StringKing20214DSG.SMS.L3.M.BLU2021-08-03
10195376202169StringKing20216DSG.SMS.L3.XL.BLU2021-08-03
10195376202244StringKing20224DSG.SMS.L4.S.BLU2021-09-17
10195376202251StringKing20225DSG.SMS.L4.M.BLU2021-09-17
10195376202268StringKing20226DSG.SMS.L4.L.BLU2021-09-17
10195376202275StringKing20227DSG.SMS.L4.XL.BLU2021-09-17
10195376202282StringKing20228DSG.SMS.L4.XXL.BLU2021-09-17
10195376202114StringKing20211DSG.SMS.L3.L.BLU2021-08-03
10195376202183StringKing20218DSG.SMS.L3.XXL.BLU2021-08-03
10195376201841StringKingDIG.SMS.L2.L.BLU2022-07-18
00195376202216StringKing20221DMM-L3-A-BLU2021-09-09
00195376202667StringKing20266DMM-L2-A-BLU2021-12-04
00195376202674StringKing20267DMM.L2.A.WHT.12021-12-04
30195376202668StringKing20266DMM.L2.A.BLU.12021-12-04
30195376202675StringKing20267DMM.L2.A.WHT.12021-12-04
30195376202248StringKing202242021-09-17
30195376202255StringKing202252021-09-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840118617567Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617581Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617604Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617628Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617659ENDURE INDUSTRIESENDURE INDUSTRIESOEA2026-08-03
00840118617673Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617697Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617710Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617741Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617772Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118617802Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118687690Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
00840118698399Endure IndustriesENDURE INDUSTRIESOEA2026-08-03
30193489103964MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489103971MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-28
30193489104893MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489107969MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120241MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40193489120258MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50080196247576MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109885MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
50193489109892MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-24
40884389804637MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
50193489108239MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-17
40080196772026MEDLINEMEDLINE INDUSTRIES, INC.OEA2026-07-03
00199536901001BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901018BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901308BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901315BluelineTransparent Supply Solutions Ltd.OEA2026-05-15
00199536901407BluelineTransparent Supply Solutions Ltd.OEA2026-05-15