FDA.reportPublic FDA data

9'' DUAL ADJUSTMENT BACK SUP

Primary DI
10609271051383
Brand
9'' DUAL ADJUSTMENT BACK SUP
Company
DARCO INTERNATIONAL, INC.
Model
232-0010-60
Catalog number
232-0010-60
Device description
Extra-large
Published
2023-02-08
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
IPYORTHOSIS, LUMBO-SACRAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IPYOrthosis, Lumbo-SacralPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10609271051383PackageGS14In Commercial Distribution
20609271051380PackageGS112In Commercial Distribution
00609271051386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1060927105138310609271051383
2060927105138020609271051380
00609271051386006092710513866092710513860609271051386

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar spine orthosisA prefabricated (non-customized) externally applied and wearable orthopaedic appliance or apparatus designed to encompass the lumbar spine region of the trunk to support or immobilize deformities, fractures, sprains, or strains of the spine. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
184231298
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
false
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
0060927120013516'' DLX POST-OP KNEE IMMOB462-0012-30462-0012-302023-02-08
0060927120015916'' DLX POST-OP KNEE IMMOB462-0012-40462-0012-402023-02-08
0060927120017316'' DLX POST-OP KNEE IMMOB462-0012-50462-0012-502023-02-08
0060927120018016'' DLX POST-OP KNEE IMMOB462-0012-60462-0012-602023-02-08
0060927120019716'' DLX POST-OP KNEE IMMOB462-0012-70462-0012-702023-02-08
0060927120033320'' DLX POST-OP KNEE IMMOB462-0014-30462-0014-302023-02-08
0060927120035720'' DLX POST-OP KNEE IMMOB462-0014-40462-0014-402023-02-08
0060927120037120'' DLX POST-OP KNEE IMMOB462-0014-50462-0014-502023-02-08
0060927120038820'' DLX POST-OP KNEE IMMOB462-0014-60462-0014-602023-02-08
0060927120039520'' DLX POST-OP KNEE IMMOB462-0014-70462-0014-702023-02-08
0060927121050920'' DLX 3-PANEL KNEE IMMOB462-0025-10462-0025-102023-02-08
0060927121060820'' DLX 3-PANEL KNEE IMMOB462-0026-10462-0026-102023-02-08
0060927121080620'' DLX 3-PANEL KNEE IMMOB462-0028-10462-0028-102023-02-08
00609271610774"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (small)"E59410E594102023-02-08
00609271610781"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (medium)"E59411E594112023-02-08
00609271610798"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (large)"E59412E594122023-02-08
00609271610804"Knee Immobilizer, Super-Lite, Contoured Stay, 12"" (x-large)"E59413E594132023-02-08
00609271610811"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (small)"E59414E594142023-02-08
00609271610828"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (medium)"E59415E594152023-02-08
00609271610835"Knee Immobilizer, Super-Lite, Contoured Stay, 16"" (large)"E59416E594162023-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00854682001967ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001974ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
00854682001981ThermaZoneINNOVATIVE MEDICAL EQUIPMENT, LLCIPY2026-04-24
06974500613432Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
16974500613439Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
00810113683072Extension Panel - Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-11-25
00810113683492ManaMomma Maternity Back BraceManamed, Inc.IPY2025-10-03
00810113683508ManaMomma Maternity Back Brace, Custom Label Manamed, Inc.IPY2025-10-03
00810113683546Tailback2-50 CureTechManamed, Inc.IPY2025-10-03
00810113682709Tailback2-48Manamed, Inc.IPY2025-09-19
00810113682884Halfback2-50Manamed, Inc.IPY2025-09-19
00810113683058Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-09-19
05391512281229ACTIVDAYINDACO SRLIPY2024-02-09
05391512281236ACTIVDAYINDACO SRLIPY2024-02-09
05391512281250ACTIVDAYINDACO SRLIPY2024-02-09
05391512281267ACTIVDAYINDACO SRLIPY2024-02-09
05391512281755ACTIVDAYINDACO SRLIPY2024-02-09
05391512281762ACTIVDAYINDACO SRLIPY2024-02-09
05391512281779ACTIVDAYINDACO SRLIPY2024-02-09
05391512281786ACTIVDAYINDACO SRLIPY2024-02-09
05391512281793ACTIVDAYINDACO SRLIPY2024-02-09
05391512281809ACTIVDAYINDACO SRLIPY2024-02-09
05391512281816ACTIVDAYINDACO SRLIPY2024-02-09
05391512286026ACTIVDAYINDACO SRLIPY2024-02-09
05391512286033ACTIVDAYINDACO SRLIPY2024-02-09
05391512286057ACTIVDAYINDACO SRLIPY2024-02-09
05391512286064ACTIVDAYINDACO SRLIPY2024-02-09
05391512286095ACTIVDAYINDACO SRLIPY2024-02-09
05391512286101ACTIVDAYINDACO SRLIPY2024-02-09
05391512286118ACTIVDAYINDACO SRLIPY2024-02-09