FDA.reportPublic FDA data

Archimed 627 Spinal Brace

Primary DI
00802357633265
Brand
Archimed 627 Spinal Brace
Company
MEDICAL SPECIALTIES INCORPORATED
Model
163326
Published
2022-12-07
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
false

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
00802357633265PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00802357633265008023576332658023576332650802357633265

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
003173028
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
00802357230846Tee Pee Thumb Protector2230842022-12-08
00802357236411ASO Speed Lacer II Ankle Stabilizer w/Stays2236412025-05-06
00802357236428ASO Speed Lacer II Ankle Stabilizer w/Stays2236422025-05-06
00802357236442ASO Speed Lacer II Ankle Stabilizer w/Stays2236442025-05-06
00802357236459ASO Speed Lacer II Ankle Stabilizer w/Stays2236452025-05-06
00802357236466ASO Speed Lacer II Ankle Stabilizer w/Stays2236462025-05-06
00802357236473ASO Speed Lacer II Ankle Stabilizer w/Stays2236472025-05-06
00802357172313Gripper 3 Knee, 12" CoolFlex1172312025-01-14
00802357172320Gripper 3 Knee, 12" CoolFlex1172322025-01-14
00802357172344Gripper 3 Knee, 12" Coolflex1172342025-01-14
00802357172351Gripper 3 Knee, 12" Coolflex1172352025-01-14
00802357172368Gripper 3 Knee, 12" Coolflex1172362025-01-14
00802357172375Gripper 3 Knee, 12" Coolflex1172372025-01-14
00802357172382Gripper 3 Knee, 12" Coolflex1172382025-01-14
00802357172399Gripper 3 Knee, 12" Coolflex1172392025-01-14
00802357234400EPIGEL W/STAYS, UNIVERSAL2234402025-01-14
00802357240012TRIPOD WRIST LACER II2240012025-01-14
00802357240029TRIPOD WRIST LACER II2240022025-01-14
00802357240043TRIPOD WRIST LACER II2240042025-01-14
00802357240050TRIPOD WRIST LACER II2240052025-01-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
16974500613439Back BraceGCMEDICA ENTERPRISE LTD.(WUXI)IPY2025-12-08
00810113683072Extension Panel - Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-11-25
00810113682709Tailback2-48Manamed, Inc.IPY2025-09-19
00810113682884Halfback2-50Manamed, Inc.IPY2025-09-19
00810113683058Zynex Pro Hybrid LSO 637Manamed, Inc.IPY2025-09-19
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
05391512286125ACTIVDAYINDACO SRLIPY2024-02-09
05391512286132ACTIVDAYINDACO SRLIPY2024-02-09
05391512286149ACTIVDAYINDACO SRLIPY2024-02-09
05391512286156ACTIVDAYINDACO SRLIPY2024-02-09
05391512285951ACTIVDAYINDACO SRLIPY2024-01-31
05391512285968ACTIVDAYINDACO SRLIPY2024-01-31
05391512285975ACTIVDAYINDACO SRLIPY2024-01-31
05391512285982ACTIVDAYINDACO SRLIPY2024-01-31
05391512285999ACTIVDAYINDACO SRLIPY2024-01-31
05391512286002ACTIVDAYINDACO SRLIPY2024-01-31
05391512286019ACTIVDAYINDACO SRLIPY2024-01-31
05391512286040ACTIVDAYINDACO SRLIPY2024-01-31
05391512286071ACTIVDAYINDACO SRLIPY2024-01-31
05391512286088ACTIVDAYINDACO SRLIPY2024-01-31
05391512286217M-Brace AirINDACO SRLIPY2024-01-30
05391512286224M-Brace AirINDACO SRLIPY2024-01-30
05391512286231M-Brace AirINDACO SRLIPY2024-01-30
05391512286255M-Brace AirINDACO SRLIPY2024-01-30