FDA.report

N/A

Primary DI
00812185033700
Brand
N/A
Company
SHIPPERT MEDICAL TECHNOLOGIES, INC
Model
3-H-BA-LV-4X25
Published
2019-06-14
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

Related Records

Product Codes

CodeName
EPPSplint, Nasal

Product Code Classifications

CodeDeviceSpecialtyClass
EPPSplint, NasalEar, Nose, Throat1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00812185033700PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00812185033700008121850337008121850337000812185033700

GMDN Terms

TermDefinition
External nasal splintA rigid or semi-rigid device intended to be applied externally to the nose for the immobilization of nasal bones and cartilage, typically after a fracture or surgery. It functions as a truss-like support on the outside of the nose. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
051437143
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
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00893398002004DENVER SPLINT10-1500-05KS2018-09-13
00893398002011DENVER SPLINT10-1500-05KL2018-09-13
00893398002035DENVER SPLINT10-4021-05KS2018-09-13
00893398002042DENVER SPLINT10-4021-05KL2018-09-13
00893398002066DENVER SPLINT10-1500-05KP2018-09-13
00893398002103DENVER SPLINT10-4021-05KM2018-09-13
00893398002110DENVER SPLINT10-4021-10NKM2018-09-20
00893398002127DENVER SPLINT10-4021-10NKL2018-09-20
00893398002530HOTSYCautery High Temperature Fine Tip20-HM-20002016-08-12
00893398002547HOTSYCautery High Temperature Loop Tip20-HM-10002016-08-12
00893398002578DENVER SPLINT10-1500-05KM2018-09-13
00893398002585DENVER SPLINT10-1800-05KL2018-09-13
00893398002592DENVER SPLINT10-1800-05KM2018-09-13
00893398002608DENVER SPLINT10-1800-05KP2018-09-13
00893398002615DENVER SPLINT10-1800-05KS2018-09-13
00893398002622DENVER SPLINT10-2000-05KL2018-09-13
00893398002639DENVER SPLINT10-2000-05KM2018-09-13
00893398002646DENVER SPLINT10-2000-05KP2018-09-13
00893398002653DENVER SPLINT10-2000-05KS2018-09-13
00893398002660DENVER SPLINT10-3000-05KL2018-09-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
04250381810255External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-28
04250381823668Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823675Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823682Aluminium Ext. Nasal Splints,Spiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823699External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823705External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823712External Thermoplastic NasalSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823729Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823736Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823743Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823750Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381823767Septal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-19
04250381809945External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809969External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809976External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381809990External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810019External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810057External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810071External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810088External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810101External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810125External thermoplastic nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810194External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810217External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381810231External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849828External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849835External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381849859External aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381851029Set external aluminium nasal splintSpiggle & Theis Medizintechnik GmbHEPP2025-09-09
04250381856338Equipment box for external nasal splintsSpiggle & Theis Medizintechnik GmbHEPP2025-09-09