FDA.reportPublic FDA data

Regard™

Primary DI
20326053102671
Brand
Regard™
Company
RESOURCE OPTIMIZATION & INNOVATION, L.L.C.
Model
70412ROI
Device description
COUNTER NDLE FM BLK W/ MAGNT
Published
2020-09-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GABNeedle, Suturing, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GABNeedle, Suturing, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10326053102674PackageGS164In Commercial Distribution
20326053102671PackageGS18In Commercial Distribution
30326053102678PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1032605310267410326053102674
2032605310267120326053102671
3032605310267830326053102678

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument containment holder, single-use, sterileA sterile device intended to be used in the operating room (OR) by staff to safely contain a delicate or sharp hand-held, manual, surgical instrument(s) [e.g., needle, scalpel, scissors] during surgery, to avoid damage to the instrument, and/or for temporary storage (e.g., to enable easy transfer/handling of the instrument at reduced risk of injury). It is available in various forms (e.g., rack, puncture cushion, telescopic tube, magnetic mat), and may be attached to a surgical drape; it is not a numbered tray and is not intended for counting of sharps. 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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
16931918121994AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-04-06
16931918157016AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2026-01-21
16931918179858AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-21
16931918144948AllesetGRI Medical & Electronic Technology Co., Ltd.GAB2025-06-20
10192253052329DevonCardinal Health 200, LLCGAB2025-05-29
10192253052138DevonCardinal Health 200, LLCGAB2025-03-27
10192253052145DevonCardinal Health 200, LLCGAB2025-03-27
10192253052152DevonCardinal Health 200, LLCGAB2025-03-27
10192253052169DevonCardinal Health 200, LLCGAB2025-03-27
10192253052176DevonCardinal Health 200, LLCGAB2025-03-27
10192253052183DevonCardinal Health 200, LLCGAB2025-03-27
10192253052190DevonCardinal Health 200, LLCGAB2025-03-27
10192253052206DevonCardinal Health 200, LLCGAB2025-03-27
10192253052213DevonCardinal Health 200, LLCGAB2025-03-27
10192253052220DevonCardinal Health 200, LLCGAB2025-03-27
10192253052237DevonCardinal Health 200, LLCGAB2025-03-27
10192253052244DevonCardinal Health 200, LLCGAB2025-03-27
10192253052251DevonCardinal Health 200, LLCGAB2025-03-27
10192253052268DevonCardinal Health 200, LLCGAB2025-03-27
10192253052275DevonCardinal Health 200, LLCGAB2025-03-27
10192253052282DevonCardinal Health 200, LLCGAB2025-03-27
10192253052299DevonCardinal Health 200, LLCGAB2025-03-27
10192253052312DevonCardinal Health 200, LLCGAB2025-03-27
10192253052336DevonCardinal Health 200, LLCGAB2025-03-27
10192253052343DevonCardinal Health 200, LLCGAB2025-03-27
10192253052350DevonCardinal Health 200, LLCGAB2025-03-27
10192253052367DevonCardinal Health 200, LLCGAB2025-03-27
10192253052374DevonCardinal Health 200, LLCGAB2025-03-27
10192253052381DevonCardinal Health 200, LLCGAB2025-03-27
10192253053357DevonCardinal Health 200, LLCGAB2025-03-27