FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
00841767106341
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
22001
Device description
VAGINAL SPECULUM MED NS
Published
2023-07-04
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
CodeName
HDFSPECULUM, VAGINAL, METAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HDFSpeculum, Vaginal, MetalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767106341PackageGS1100In Commercial Distribution
10841767106348PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767106341008417671063418417671063410841767106341
1084176710634810841767106348

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal speculum, single-useA 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
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
154424043
Device count
1
DM exempt
true
Premarket exempt
false
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 DIBrandModelCatalogPublished
50649111345775Trinity Sterile, Inc.94-19242024-12-16
50649111492691Trinity Sterile, Inc.96-3566A2024-12-16
50649111449701Trinity Sterile, Inc.96-36152024-12-16
10841767198275Trinity Sterile, Inc.T97-7052025-01-06
10841767101084Trinity Sterile, Inc.T97-7482024-10-30
10841767101091Trinity Sterile, Inc.T97-7512024-10-30
10841767198282Trinity Sterile, Inc.T97-7102024-10-30
10841767198312Trinity Sterile, Inc.T97-7422024-10-30
10841767198374Trinity Sterile, Inc.T97-7712024-10-30
10841767198381Trinity Sterile, Inc.T97-7722024-10-30
10841767198398Trinity Sterile, Inc.T97-7752024-10-30
10841767198404Trinity Sterile, Inc.T97-7762024-10-30
10841767198411Trinity Sterile, Inc.T97-7772024-10-30
10841767198428Trinity Sterile, Inc.T97-7782024-10-30
10841767101237Trinity Sterile, Inc.T98-8012024-10-28
10841767101114Trinity Sterile, Inc.T97-7932024-10-25
10841767198442Trinity Sterile, Inc.T97-7912024-10-25
10841767198466Trinity Sterile, Inc.T97-8102024-10-25
10841767198473Trinity Sterile, Inc.T97-8322024-10-25
10841767198497Trinity Sterile, Inc.T97-8472024-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776418274MillenniumAvalign Technologies, Inc.HDF2026-03-23
B356JB543320American MedicalsAmerican MedicalsHDF2026-02-26
00198506088810ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-25
00198506088773ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00198506088780ELMED INCORPORATEDELMED INCORPORATEDHDF2026-02-23
00190776416164MillenniumAvalign Technologies, Inc.HDF2026-02-06
00190776416171MillenniumAvalign Technologies, Inc.HDF2026-02-06
B356JB641170American MedicalsAmerican MedicalsHDF2026-02-06
00190776415594MillenniumAvalign Technologies, Inc.HDF2026-01-28
00190776415259MillenniumAvalign Technologies, Inc.HDF2026-01-27
00190776415266MillenniumAvalign Technologies, Inc.HDF2026-01-27
00198506088278ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-27
00198506087752ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087769ELMED INCORPORATEDELMED INCORPORATEDHDF2026-01-16
00198506087202ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-18
00198506087066ELMED INCORPORATEDELMED INCORPORATEDHDF2025-12-17
00190776415136MillenniumAvalign Technologies, Inc.HDF2025-12-03
00810158218062PRINCETONPrinceton Medical Group, Inc.HDF2025-11-17
M803030915Kogan 2-4mm w/screwMEDGYN PRODUCTS, INC.HDF2025-11-16
00198506067815ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506067822ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00198506068324ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-19
00190776410650MillenniumAvalign Technologies, Inc.HDF2025-09-11
00198506085161ELMED INCORPORATEDELMED INCORPORATEDHDF2025-09-05
00190776409258MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776409289MillenniumAvalign Technologies, Inc.HDF2025-08-22
00190776408589MillenniumAvalign Technologies, Inc.HDF2025-08-19
00190776407995MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408008MillenniumAvalign Technologies, Inc.HDF2025-08-06
00190776408077MillenniumAvalign Technologies, Inc.HDF2025-08-06