FDA.reportPublic FDA data

Regard™

Primary DI
10326053121194
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
STCTK2PL6ST-REG
Catalog number
STCTK2PL6ST-REG
Device description
6" X 60" COTTON DOUBLE-PLY STERILE
Published
2023-11-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FQLStocking, Medical Support (For General Medical Purposes)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FQLStocking, Medical Support (For General Medical Purposes)General Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053121194PackageGS115In Commercial Distribution
00326053121197PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1032605312119410326053121194
00326053121197003260531211973260531211970326053121197

GMDN Terms#

Term, Definition table
TermDefinition
StockinetteA knitted, seamless, expandable tubing, typically made of cotton, that is open at both ends and intended to be used to hold bandages in place; to place uniform pressure on a leg, finger, arm, or other part of an extremity; to pad the area under a cast or splint; or to cover a stump when a prosthesis is worn. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
134472476
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
false
Expiration date on label
false
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
20326053123522Regard™TLPCHCLR-REG2026-03-11
20326053123539Regard™TLPCHSTRP-REG2026-03-11
10326053103015Regard™UN 401UN 4012023-08-17
10326053117340Regard™AN10842019-09-18
10326053118071Regard™DSPSCRBSHRTL-REGDSPSCRBSHRTL-REG2023-01-11
10326053118088Regard™DSPSCRBSHRTM-REGDSPSCRBSHRTM-REG2023-01-11
10326053118095Regard™DSPSCRBSHRTXL-REGDSPSCRBSHRTXL-REG2023-01-11
10326053118101Regard™DSPSCRBSHRTXXL-REGDSPSCRBSHRTXXL-REG2023-01-11
10326053118118Regard™DSPSCRBPNTL-REGDSPSCRBPNTL-REG2023-01-11
10326053118125Regard™DSPSCRBPNTM-REGDSPSCRBPNTM-REG2023-01-11
10326053118132Regard™DSPSCRBPNTXL-REGDSPSCRBPNTXL-REG2023-01-11
10326053118149Regard™DSPSCRBPNTXXL-REGDSPSCRBPNTXXL-REG2023-01-11
10326053118156Regard™CHMG38GNSM-REGCHMG38GNSM-REG2023-01-10
10326053118163Regard™CHMG38GNSL-REGCHMG38GNSL-REG2023-01-10
10326053118170Regard™CHMG38GNSXL-REGCHMG38GNSXL-REG2023-01-10
10326053118187Regard™CHMG38GNS2XL-REGCHMG38GNS2XL-REG2023-01-10
10326053118194Regard™CHMG53GNSM-REGCHMG53GNSM-REG2023-01-10
10326053118200Regard™CHMG53GNSL-REGCHMG53GNSL-REG2023-01-11
10326053118217Regard™CHMG53GNSXL-REGCHMG53GNSXL-REG2023-01-11
10326053118224Regard™CHMG53GNS2XL-REGCHMG53GNS2XL-REG2023-01-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613378196522862P-CUSTOM ECF2 AT SoftTop MEN BlackSIGVARIS INCFQL2026-07-22
07613378196911862P-CUSTOM ECF2 AT SoftTop MEN °° CaramelSIGVARIS INCFQL2026-07-22
07613378197307862P-CUSTOM ECF2 AT SoftTop MEN CaramelSIGVARIS INCFQL2026-07-22
07613378197697862P-CUSTOM ECF2 AT SoftTop MEN °° GreySIGVARIS INCFQL2026-07-22
07613378198083862P-CUSTOM ECF2 AT SoftTop MEN GreySIGVARIS INCFQL2026-07-22
07613378198472862P-CUSTOM ECF2 AT SoftTop MEN °° SavannaSIGVARIS INCFQL2026-07-22
07613378198861862P-CUSTOM ECF2 AT SoftTop MEN SavannaSIGVARIS INCFQL2026-07-22
07613378199257862P-CUSTOM ECF2 AT SoftTop MEN °° SkinSIGVARIS INCFQL2026-07-22
07613378199646862P-CUSTOM ECF2 AT SoftTop MEN SkinSIGVARIS INCFQL2026-07-22
07613378277542862P-CUSTOM ECF2 AT SoftTop MEN marineSIGVARIS INCFQL2026-07-22
07613378277931862P-CUSTOM ECF2 AT SoftTop MEN °° marineSIGVARIS INCFQL2026-07-22
07613378196133862P-CUSTOM ECF2 AT SoftTop MEN °° BlackSIGVARIS INCFQL2026-07-20
07613378196539862P-CUSTOM ECF2 AT SoftTop FEM BlackSIGVARIS INCFQL2026-07-20
07613378196928862P-CUSTOM ECF2 AT SoftTop FEM °° CaramelSIGVARIS INCFQL2026-07-20
07613378197314862P-CUSTOM ECF2 AT SoftTop FEM CaramelSIGVARIS INCFQL2026-07-20
07613378197703862P-CUSTOM ECF2 AT SoftTop FEM °° GreySIGVARIS INCFQL2026-07-20
07613378198090862P-CUSTOM ECF2 AT SoftTop FEM GreySIGVARIS INCFQL2026-07-20
07613378198489862P-CUSTOM ECF2 AT SoftTop FEM °° SavannaSIGVARIS INCFQL2026-07-20
07613378198878862P-CUSTOM ECF2 AT SoftTop FEM SavannaSIGVARIS INCFQL2026-07-20
07613378199264862P-CUSTOM ECF2 AT SoftTop FEM °° SkinSIGVARIS INCFQL2026-07-20
07613378199653862P-CUSTOM ECF2 AT SoftTop FEM SkinSIGVARIS INCFQL2026-07-20
07613378277535862P-CUSTOM ECF2 AT SoftTop FEM marineSIGVARIS INCFQL2026-07-20
07613378277924862P-CUSTOM ECF2 AT SoftTop FEM °° marineSIGVARIS INCFQL2026-07-20
G4200211Compression StockingGottfried Medical, Inc.FQL2026-06-04
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G4201021Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201031Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201041Compression StockingGottfried Medical, Inc.FQL2026-06-04
G4201061Compression StockingGottfried Medical, Inc.FQL2026-06-04