FDA.reportPublic FDA data

ALLEN

Primary DI
00615521021160
Brand
ALLEN
Company
HILL-ROM, INC.
Model
101004
Catalog number
R-644-36
Device description
WEIGHTLESS SHOULDER SUSPENSION SYS
Published
2023-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
00615521021160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00615521021160006155210211606155210211600615521021160

GMDN Terms#

Term, Definition table
TermDefinition
Operating table traction frameA support structure intended to be fixed to an operating table to provide a fixation point for providing traction to skeletal fractures (e.g., pelvis) during an operative procedure, typically open reduction and fixation of the fracture. It is made of metal and has various forms for different applications and tables; it may be sterilized if used within the sterile field. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(315)685-2834GDSN_SUPPORT@MYHILLROM.ONMICROSOFT.COM
+1(800)445-3730us.customerservice@hill-rom.com

Regulatory Flags#

DUNS number
004245668
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00615521014599ALLEN102001F-LHMAQ2023-05-30
00615521031459ALLEN102001F-10056MAQ2023-05-30
00615521031466ALLEN102001F-10057MAQ2023-05-30
00615521012649ALLEN106002F-100152023-05-26
00615521013783ALLEN107002F-ABSLT2023-05-26
00615521014506ALLEN102001F-LH720MAQ2023-05-26
00615521002848ALLEN1030062026-04-24
00615521031008ALLEN1010052026-04-24
00615521031015ALLEN1010052026-04-24
00615521031022ALLEN1020082026-04-24
00615521070007ALLEN1030062026-04-24
00848340016806ALLENA-212002026-04-24
00887761981720Heart and Respiration Rate Monitoring System powered by EarlySenseP2115602021-09-23
00887761985155Heart and Respiration Rate Monitoring System powered by EarlySenseP2008982018-08-22
00887761976870pro+P7924ARENT022026-04-21
00887761007536pro+P3255A072026-04-20
00887761007543pro+P3255A082026-04-20
00887761976863pro+P7924ARENT012026-04-20
00887761976887pro+P3255ARENT012026-04-20
00887761943148WAVE Clinical PlatformDB2026-03-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776415174MillenniumAvalign Technologies, Inc.HST2025-12-03
00842430116728TRAPEZE ARM ASSEMBLY, PATIENT HELPERMIZUHO ORTHOPEDIC SYSTEMS, INC.HST2025-07-28
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
00615521021177ALLENHILL-ROM, INC.HST2023-07-31
00615521021184ALLENHILL-ROM, INC.HST2023-07-31