Home GUDID 00841767106358 Trinity Sterile, Inc.
Primary DI 00841767106358
Brand Trinity Sterile, Inc.
Company Trinity Sterile, Inc.
Model 22101
Device description VAGINAL SPEC MED W/O LGHT COMP
Published 2023-07-28
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx false
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name HIB Speculum, vaginal, nonmetal
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00841767106358 Package GS1 100 In Commercial Distribution 40841767106356 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00841767106358 00841767106358 841767106358 0841767106358 40841767106356 40841767106356
GMDN Terms# Term, Definition table Term Definition Vaginal speculum, single-use A hand-held manual instrument intended to dilate the vagina after insertion, typically for visual examination of the vaginal canal and cervix and/or to perform a gynaecological procedure. It typically consists of two long blades, joined at a handle at one end, that are inserted into the vagina in a horizontal position and then opened to form an angle, or it is a soft-material device inflated after insertion that allows viewing and access through a central channel. It is typically made entirely of plastic materials or has removable blades made of plastic. This is a single-use device.
Sterilization Methods# Method table Method Ethylene Oxide
Regulatory Flags# DUNS number 154424043 Device count 1 DM exempt true Premarket exempt true HCT/P false Kit true Combination product false Lot or batch true Serial number true Manufacturing date on label false Expiration date on label false Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10841767104696 Trinity Sterile, Inc. 82604 2023-07-28 10841767104795 Trinity Sterile, Inc. 81211 2023-06-07 10841767104818 Trinity Sterile, Inc. 81217 2023-06-07 10841767104825 Trinity Sterile, Inc. 81228 2023-06-07 10841767104849 Trinity Sterile, Inc. 81229A 2023-06-07 10841767104962 Trinity Sterile, Inc. 81248 2023-06-05 10841767104979 Trinity Sterile, Inc. 81249 2023-06-05 10841767104986 Trinity Sterile, Inc. 81243 2023-06-07 10841767105143 Trinity Sterile, Inc. 81655 2023-04-04 10841767105181 Trinity Sterile, Inc. 81254B 2023-06-05 10841767105211 Trinity Sterile, Inc. 81651 2023-03-29 10841767105327 Trinity Sterile, Inc. 81664 2023-06-02 10841767105334 Trinity Sterile, Inc. 81353 2023-06-05 10841767106614 Trinity Sterile, Inc. 81345 2023-06-05 10841767106621 Trinity Sterile, Inc. 81371 2023-06-02 10841767106645 Trinity Sterile, Inc. 81428 2023-06-02 10841767106652 Trinity Sterile, Inc. 81432 2023-04-05 10841767106720 Trinity Sterile, Inc. 81663 2023-04-04 10841767106737 Trinity Sterile, Inc. 81666 2023-06-02 10841767106744 Trinity Sterile, Inc. 81667 2023-05-31
Other Devices Sharing Product Codes#