FDA.reportPublic FDA data

Paradigm

Primary DI
10845854083048
Brand
Paradigm
Company
Conmed Corporation
Model
PRMB
Catalog number
PRMB
Device description
Paradigm Revolution Medium Boot, Pair
Published
2023-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSTApparatus, traction, non-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10845854083048Direct MarkingGS10
30845854083042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1084585408304810845854083048
3084585408304230845854083042

GMDN Terms#

Term, Definition table
TermDefinition
Traction bootAn orthopaedic device designed as an open boot that is attached and tightly secured with laces or straps to the foot or both feet of the patient so that traction can be applied to the patient's body. It is typically used during an orthopaedic surgical trauma intervention when traction is being applied to a patient's leg or legs when broken leg bones are being drawn apart, repositioned, and set to the correct position, or in conjunction with a traction table for the application of traction to the patient's spine. It is available in various foot sizes and has a solid sole construction that can be securely attached/locked to other components of the table. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00KEEP DRY
Storage Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius
Storage Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)426-6633CustomerExperience@conmed.com

Regulatory Flags#

DUNS number
071595540
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
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
10845854051399AirSealiAS8-dViAS8-dV2021-08-22
10845854084137AirSeal®iAS8-dVLiAS8-dVL2023-01-06
10845854013137QUICKLATCHQL4300QL43002020-12-10
10845854031841CONMEDT2531T25312020-12-10
10845854036204POWERPROPRO6185PRO61852023-09-01
20845854061807SnapEvacSNAPEVAC20SNAPEVAC202020-06-06
30653405011907EXCEL60-6050-00160-6050-0012016-09-24
30653405988346Argo KnotlessK55RTAPK55RTAP2023-01-13
30653405988360Argo KnotlessK475RTAPK475RTAP2023-01-13
10845854032619CROSSFTTFT-45MTFT-45M2021-01-19
10845854032633CROSSFTTFT-55MTFT-55M2021-01-19
10845854032657CROSSFTTFT-65MTFT-65M2021-01-19
10653405004646ELECTROLASE HYFRECATOR7-100-8BX7-100-8BX2016-09-24
10653405013785THERMOGARD7-3847-3842016-09-24
10845854650134THERMOGARD7-3827-3822022-09-21
20653405051906Precisor0008520008522016-09-24
20653405051920Precisor0008540008542016-09-24
30653405046800BiCap SuperconductorBP-10300ABP-10300A2016-09-24
30653405046992BiCap SuperconductorBP-7300ABP-7300A2016-09-24
30653405047005BiCap SuperconductorBP-5200ABP-5200A2016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00887482122723Symmetry LoganASPEN SURGICAL PRODUCTS, INC.HST2024-08-20
00615521004712ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004736ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004750ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004828ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00615521004842ArthrexALLEN MEDICAL SYSTEMS, INC.HST2024-05-23
00840277130495Innomed, Inc.INNOMED, INC.HST2024-05-09
00860011457800IHNIHN, Inc.HST2024-02-07
00860011457817IHNIHN, Inc.HST2024-02-07
10860011457807IHNIHN, Inc.HST2024-02-07
10860011457814IHNIHN, Inc.HST2024-02-07
00840277129444Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129451Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129468Innomed,Inc.INNOMED, INC.HST2023-12-19
00840277129475Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129482Innomed, Inc.INNOMED, INC.HST2023-12-19
00840277129499Innomed, Inc.INNOMED, INC.HST2023-12-19
00724995225544NASTERIS CORPORATIONHST2023-11-17
00860011173618AFTHILL LABORATORIES CO.HST2023-10-23
00860011173625Air Drop AFTHILL LABORATORIES CO.HST2023-10-23
00860001452570Air Flex IIHILL LABORATORIES CO.HST2023-10-16
04719871180167EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
04719871180365EVERYWAY4ALLEVERYWAY MEDICAL INSTRUMENTS CO., LTD.HST2023-08-24
00615521001490ALLENHILL-ROM, INC.HST2023-07-31
00615521001506ALLENHILL-ROM, INC.HST2023-07-31
00615521012823ALLENHILL-ROM, INC.HST2023-07-31
00615521021160ALLENHILL-ROM, INC.HST2023-07-31
00615521021177ALLENHILL-ROM, INC.HST2023-07-31