ETHICON MS1995

GUDID 20705031131955

Surgiflo Endoscopic Appicator

ETHICON INC.

Haematological concentrate/haemostatic agent cannula, endoscopic, single-use

• Primary Device ID: 20705031131955
• NIH Device Record Key: 1948e756-563f-475b-a030-55c86b2fd12a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ETHICON
• Version Model Number: MS1995
• Catalog Number: MS1995
• Company DUNS: 002144145
• Company Name: ETHICON INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx
• Phone: +1(877)384-4266
• Email: xxx@xxx.xxx

Operating and Storage Conditions

• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 59 Degrees Fahrenheit and 86 Degrees Fahrenheit
• Storage Environment Temperature: Between 15 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10705031131958 [Primary]
GS1	20705031131955 [Package]; Contains: 10705031131958; Package: CASE [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051732

FDA Product Code

• GCJ: Laparoscope, general & plastic surgery

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-07-22
• Device Publish Date: 2015-09-23

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• 20705031230139: Evicel Airless Spray Accessory
• 20705031147833: EVICEL 4CM CONTROL TIP (SET OF 10)
• 20705031131955: Surgiflo Endoscopic Appicator
• 10705031007239: EVICEL 5 ML DEVICE
• 10705031007215: EVICEL 1/2 ML DEVICE
• 20705031005089: EVICEL 45CM FLEXIBLE TIP (SET OF 3)
• 20705031005072: EVICEL 35 CM APPLICATOR TIP
• 30705031238903: Pull-out Suture Set Surgical Steel w/ Monofilament 316L Stainless Steel 4-0 8" Loop
• 20705031036823: BONE WAX
• 30705031462728: Laparoscopic Dual Flexible Applicator
• 20705031462578: Laparoscopic Dual Rigid Applicator
• 20705031462530: VISTASEAL DUAL APPLICATOR
• 30705031050413: Chromic Suture Chromic Monofilament
• 30705031028962: Chromic Gut, Sterile, Absorbable Surgical Suture
• 10705031228139: CO2 Pressure Regulator