FDA.reportPublic FDA data

Trinity Sterile, Inc.

Primary DI
00841767105108
Brand
Trinity Sterile, Inc.
Company
Trinity Sterile, Inc.
Model
22100
Device description
VAG SPEC SM W/O LIGHT 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
CodeName
HIBSpeculum, vaginal, nonmetal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HIBSpeculum, Vaginal, NonmetalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841767105108PackageGS1100In Commercial Distribution
40841767105106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841767105108008417671051088417671051080841767105108
4084176710510640841767105106

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

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 DIBrandModelCatalogPublished
10841767195717Trinity Sterile, Inc.500502026-08-25
10841767104696Trinity Sterile, Inc.826042023-07-28
10841767104795Trinity Sterile, Inc.812112023-06-07
10841767104818Trinity Sterile, Inc.812172023-06-07
10841767104825Trinity Sterile, Inc.812282023-06-07
10841767104849Trinity Sterile, Inc.81229A2023-06-07
10841767104962Trinity Sterile, Inc.812482023-06-05
10841767104979Trinity Sterile, Inc.812492023-06-05
10841767104986Trinity Sterile, Inc.812432023-06-07
10841767105143Trinity Sterile, Inc.816552023-04-04
10841767105181Trinity Sterile, Inc.81254B2023-06-05
10841767105211Trinity Sterile, Inc.816512023-03-29
10841767105327Trinity Sterile, Inc.816642023-06-02
10841767105334Trinity Sterile, Inc.813532023-06-05
10841767106614Trinity Sterile, Inc.813452023-06-05
10841767106621Trinity Sterile, Inc.813712023-06-02
10841767106645Trinity Sterile, Inc.814282023-06-02
10841767106652Trinity Sterile, Inc.814322023-04-05
10841767106720Trinity Sterile, Inc.816632023-04-04
10841767106737Trinity Sterile, Inc.816662023-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199536930063BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930070BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930087BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930094BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930100BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00199536930117BluelineTransparent Supply Solutions Ltd.HIB2026-08-07
00888937027389OfficeSPECCoopersurgical, Inc.HIB2026-08-06
00888937027396HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027402HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027419HER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027426ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027433ER-SPECCoopersurgical, Inc.HIB2026-08-06
00888937027440ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027457ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027464ER-SpecCoopersurgical, Inc.HIB2026-08-06
00888937027327ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027334ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027341ER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027358HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027365HER-SpecCoopersurgical, Inc.HIB2026-08-05
00888937027372HER-SpecCoopersurgical, Inc.HIB2026-08-05
00860015815705Rosa SpeculumMY VILLAGE INNOVATIONS INC.HIB2026-07-20
20860000270421Nella Next Reusable Vaginal SpeculumCEEK WOMEN'S HEALTHHIB2026-06-25
00860000270496Nella Comfort Kit First Time ExamCEEK WOMEN'S HEALTHHIB2026-05-05
00860000270472Nella Comfort Kit Classic RetailCEEK WOMEN'S HEALTHHIB2026-04-15
00860000270489Nella Comfort Kit Curves RetailCEEK WOMEN'S HEALTHHIB2026-04-15
10860008900309ClearSpecClearspec LLCHIB2025-10-29
10860008900316ClearSpecClearspec LLCHIB2025-10-29
10860008900323ClearSpecClearspec LLCHIB2025-10-29
10860008900330ClearSpecClearspec LLCHIB2025-10-29