| Primary Device ID | B3961501540 |
| NIH Device Record Key | c542bc16-481b-4649-a1ed-7760e2a874e4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ESI |
| Version Model Number | 15-0154 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B3961501540 [Primary] |
| GCF | Proctoscope |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
[B3961501540]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-09-18 |
| Device Publish Date | 2016-09-16 |
| B396SK2219820 | CUSTOM MFG'D YANKAUER SUCTION TUBE, ACMI FITTING. PER DRAWING SK-22198-2. |
| B396MSK1122110 | CUSTOM FRAZIER SUCTION, 30 DEGREE. INSTRUMENT HAS 5.5" WORKING LENGTH. ACMI FITTING. |
| B396MSK1116050 | MIRA TRANSILLUMINATOR/ PILLING EYE LIGHT. ACMI FITTING. |
| B396MSK1009120 | LIGHT ATTACHMENT FOR MEGADYNE CAUTERY PEN. ACMI FITTING. |
| B396MSK1002060 | CUSTOM SUCTION- 14" BUIE SUCTION TUBE WITH LIGHT CARRIER, ACMI FITTING. |
| B396MSK0827140 | CUSTOM YEOMAN LIGHT CARRIER FOR CODMAN RETRACTOR. |
| B396MSK0812090 | CUSTOM 12CM PROCTOSCOPE, INSULATED. |
| B396MSK0808050 | CUSTOM LARGE ROCHESTER STYLE HIRSCHMAN ANOSCOPE, ACMI FITTING. |
| B396MSK0715140 | CUSTOM METALLIC SALVATI, 3.8CM X 9CM. |
| B396MSK0601060 | CUSTOM LIGHT CARRIER ADAPTOR FOR KAPP SURGICAL SCOPES, ACMI FITTING. |
| B396MSK0518120 | CUSTOM TAPERED ANOSCOPE. NO FIBEROPTIC LIGHT. |
| B396MSK0506030 | LIGHT CARRIER ADAPTOR FOR CAMERON-MILLER SCOPES. |
| B396MSK0501150 | DILATING WINDOW FOR HALO ULTRASONIC PROCTOSCOPE. |
| B396MSK0427120 | CUSTOM ESI ULTRASOUND INTRODUCING PROCTOSCOPE. ACMI FITTING. |
| B396MSK0422110 | MSK042211 |
| B396MSK0328120 | CUSTOM ESI FRAZIER SUCTION TUBE, 30 DEGREE, 2" WORKING LENGTH. ACMI FITTING |
| B396MSK0314110 | LIGHTED YANKAUER 35CM OVERALL |
| B396MSK0306120 | CUSTOM SMALL CCF STYLE HIRSCHMAN ANOSCOPE WITH BLACK OBTURATOR. ACMI FITTING. |
| B396MSK0112120 | CUSTOM LENGTH BARR-SHUFORD ANOSCOPE. NO FIBEROPTIC LIGHT. (INSTRUMENT IS REV. A ) |
| B396MSK0110120 | PROLAPSE PURSE STRING ANOSCOPE. ACMI FITTING. |
| B396MSK0104130 | CUSTOM FRAZIER SUCTION, 7", 30 DEGREE. LIGHT CARRIER 5MM FROM TIP OF SUCTION. ACMI FITTING. |
| B3968701340 | REPLACEMENT FIBER OPTIC LIGHT CARRIER, ACMI FITTING. FOR ENDOCAVITY IRRADIATION PROCTOSCOPES. |
| B3964501000 | SNARE CORD TO FIT CUSTOMER SPECIFIED POWER UNIT. |
| B3964500800 | SNARE CORD TO CONNECT ESI RECTAL CAUTERY SNARE AND BOVIE OR VALLEY LABS POWER UNIT |
| B3964500600 | LIGHT & SUCTION ATTACHMENT FOR CAUTERY PENCIL. ACMI FITTING. |
| B3964500540 | ESI SUCTION CAUTERY, 3MM BALL, 37 CM. |
| B3964500500 | ESI SUCTION CAUTERY, 6MM BALL, 37CM. |
| B3964500320 | BALL ELECTRODE, USE WITH SNARE, 3MM. |
| B3964500300 | BALL ELECTRODE FOR CAUTERY SNARE, 6MM BALL. |
| B3964500200 | DISPOSABLE SNARE WIRES, STRANDED WIRE, ONE DOZEN. |
| B3964500180 | DISPOSABLE SNARE WIRES, SOFT WIRE, ONE DOZEN. |
| B3964500160 | DISPOSABLE SNARE WIRES, SPRING WIRE, ONE DOZEN. |
| B3964500140 | SNARE EXTENSION TUBE ONLY. |
| B3964102760 | Rectal Suction Tube for Cleveland Clinic |
| B3964102740 | ATRAUMATIC SUCTION TUBE, 35CM. |
| B3964102690 | SUCTION TUBE. |
| B3964102680 | BUIE SUCTION TUBE |
| B3963728300 | REPLACEMENT LOADING CONE FOR SUCTION LIGATOR, DELRIN. |
| B3963728240 | SUCTION LIGATOR WITH LOADING CONE AND 100 RINGS, ANGLED DOWN. (Caution: This Product Contains Na |
| B3963728220 | SUCTION LIGATOR WITH LOADING CONE AND 100 RINGS, ANGLED UP. (Caution: This Product Contains Natu |
| B3963728200 | SUCTION LIGATOR WITH LOADING CONE AND 100 RINGS, STRAIGHT. (Caution: This Product Contains Natur |
| B3963728000 | REPLACEMENT LOADING CONE FOR SUCTION LIGATOR. STAINLESS. |
| B3963708140 | LIGATING RING REMOVER. |
| B3963708130 | NON-LATEX LIGATING RINGS, PACKAGE OF 100 |
| B3963708120 | LIGATING RINGS, PACKAGE OF 100. (Caution: This Product Contains Natural Rubber Latex Which May C |
| B3963708110 | LOADING CONE FOR MC GIVNEY LIGATOR. |
| B396370810C0 | MCGIVNEY HEMORRHOIDAL LIGATOR WITH LOADING CONE, 100 RINGS AND ANGLED FORCEPS. (Caution: This Pr |
| B3963708100 | McGIVNEY LIGATOR SET WITH LOADING CONE AND 100 RINGS. (Caution: This Product Contains Natural Ru |
| B3961600620 | YANKAUER SUCTION TUBE, PEDIATRIC SIZE. ACMI FITTING. |
| B396160060T0 | SPARE TIP FOR YANKAUER SUCTION. |