FDA.reportPublic FDA data

RTMED

Primary DI
06971642800072
Brand
RTMED
Company
Shandong Haidike Medical Products Co., Ltd.
Model
12.5cm×75cm
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
true

Product Codes#

Code, Name table
CodeName
HSPSplint, Traction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSPSplint, TractionOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06971642800072PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06971642800072069716428000726971642800072

GMDN Terms#

Term, Definition table
TermDefinition
Arm splint system, self-mouldingA collection of non-sterile devices designed to produce a moulded splint that is formed around the upper limb of a patient who requires support or immobilization (e.g., to treat fractures, injuries, strains, sprains). It typically consists of a two-component polyurethane that is mixed and poured into a textile which matches this part of the body creating a rigid or soft foam splint that is applied to the patient’s arm where it sets. It is available in different sizes. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
550402542
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
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
06971642801390RTMED2/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642801413RTMED2/0 75cm Cutting 3/8 30mm2024-02-22
06971642804285RTMED2 Without Needle 150cm2024-02-22
06971642804292RTMED6/0 Without Needle 150cm2024-02-22
06971642804308RTMED5/0 75cm Cutting 3/8 16mm2024-02-22
06971642804315RTMED5/0 75cm Round Bodied 1/2 13mm2024-02-22
06971642804322RTMED5/0 Without Needle 150cm2024-02-22
06971642804346RTMED4/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804353RTMED4/0 75cm Round Bodied 1/2 16mm2024-02-22
06971642804360RTMED4/0 Without Needle 150cm2024-02-22
06971642804377RTMED3/0 75cm Reverse Cutting 3/8 19mm2024-02-22
06971642804384RTMED3/0 75cm Cutting 3/8 24mm2024-02-22
06971642804391RTMED3/0 75cm Reverse Cutting 3/8 26mm2024-02-22
06971642804407RTMED3/0 75cm Cutting 3/8 30mm2024-02-22
06971642804414RTMED3/0 75cm Round Bodied 1/2 30mm2024-02-22
06971642804421RTMED3/0 Without Needle 150cm2024-02-22
06971642801420RTMED2/0 75cm Round Bodied 1/2 24mm2024-02-23
06971642801437RTMED2/0 75cm Round Bodied 1/2 35mm2024-02-23
06971642801444RTMED2/0 Without Needle 150cm2024-02-23
06971642801451RTMED0 75cm Reverse Cutting 3/8 37mm2024-02-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974567745909RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
16974567745906RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2024-05-13
06974567746937RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
16974567746934RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-06-28
05060483570051Prometheus Traction Splint SAFEGUARD MEDICAL TECHNOLOGIES LIMITEDHSP2023-05-01
16952534421022SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421039SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421046SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421053SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421060SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421114SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421121SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421138SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421145SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421152SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
16952534421169SenoloJIANGSU SENOLO MEDICAL TECHNOLOGY CO., LTD.HSP2023-04-06
06974567747811RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567747828RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-21
06974567748092RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03
16974567748099RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-03-03
26974567748133RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748140RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748157RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
26974567748164RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-27
06974567748139RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748146RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748153RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
06974567748160RHINO RESCUEWuxi Emsrun Technology Co., Ltd.HSP2023-02-20
10609271080604BUCKS TRACTION w/LINERDARCO INTERNATIONAL, INC.HSP2023-02-08
06971642800034RTMEDShandong Haidike Medical Products Co., Ltd.HSP2022-12-07