ESI GloSpec 14-0310

GUDID B3961403102

Single use vaginal speculum with built in light source size small

FTT MEDICAL, INC.

Vaginal speculum, single-use

• Primary Device ID: B3961403102
• NIH Device Record Key: 669b06b7-05d8-406a-a29a-5404b7941e35
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ESI GloSpec
• Version Model Number: 140310
• Catalog Number: 14-0310
• Company DUNS: 002212793
• Company Name: FTT MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3961403100 [Primary]
HIBCC	B3961403101 [Package]; Contains: B3961403100; Package: BOX [25 Units]; In Commercial Distribution
HIBCC	B3961403102 [Package]; Contains: B3961403100; Package: Case [100 Units]; In Commercial Distribution

FDA Product Code

• HIB: Speculum, Vaginal, Nonmetal

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

Devices Manufactured by FTT MEDICAL, INC.

• B3961600020 - ESI: 2020-04-20 SPECIAL SUCTION TUBE
• B396160004A0 - ESI: 2020-04-20 ESI LITE-PIPE SUCTION TUBE, 3/16", ACMI FITTING.
• B3961600100 - ESI: 2020-04-20 FRAZIER SUCTION TUBE, 75 DEGREE, 7". ACMI FITTING.
• B3961600120 - ESI: 2020-04-20 FRAZIER SUCTION TUBE, 7", 30 DEGREE. ACMI FITTING.
• B396160012S0 - ESI: 2020-04-20 STYLET ONLY FOR FRAZIER SUCTION, 30 DEGREE, 7" LONG. SPECIFY FRENCH SIZE WHEN ORDERING.
• B3961600140 - ESI: 2020-04-20 FRAZIER SUCTION TUBE, 9", 30 DEGREE. ACMI FITTING.
• B3961600150 - ESI: 2020-04-20 CUSTOM FRAZIER SUCTION TUBE, 10 FRENCH, 90 DEGREE ANGLE, CUSTOM LENGTH, ACMI FITTING.
• B3961600600 - ESI: 2020-04-20 YANKAUER SUCTION, STANDARD SIZE. ACMI FITTING.