Vitalitec Clip Appliers

GUDID 00850001784382

PRE119-1B (Small Red 19cm Ethicon Style Applier, One Ring Red, One Ring Black, Vi...

VITALITEC INTERNATIONAL, INC.

Open-surgery ligation clip applier
Primary Device ID00850001784382
NIH Device Record Key9ddcbe37-9bbf-497f-9653-cbcdd77ac27b
Commercial Distribution StatusIn Commercial Distribution
Brand NameVitalitec Clip Appliers
Version Model NumberPRE119-1B
Company DUNS121464288
Company NameVITALITEC INTERNATIONAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone508.747.6033
Emaillylehoward@aol.com

Device Dimensions

Length19 Centimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100850001784382 [Primary]

FDA Product Code

HBTApplier, Hemostatic Clip

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00850001784382]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-08-21
Device Publish Date2018-12-13

On-Brand Devices [Vitalitec Clip Appliers]

00857987006996GEM715-SF (Superfine Micro Applier, 15cm, GEM Logo and Label, Polished Silver Rin.)
00857987006989GEM620-1 (Micro Applier-MCA, 19cm, gold ring handles for micro clips, Labeled: GE)
00857987006972GEM615 (Micro Applier- MCA, 15cm length, gold ring handles, labeled: GEM615-1G)
00857987006965PBTN220-1B (20 cm medium applier nitonal spring)
00857987006958PBT220-1B (Lite Med Applier, Soft Spring, 20cm Length, 19deg Angle VITALITEC LOGO...
00857987006941PBE228-1B (Medium 28 Ethicon Applier)
00857987006934PBC228-EB (Medium Light C Applier, FS 28cm)
00857987006927PBC228-E (Medium Clip Applier,28cm E Etched)
00857987006910PBC228-1B (Medium Applier, 28cm Length, Angled, VITALITEC LOGO AND PRT NUMBER)
00857987006903PBC228-1 (Medium Clip Applier, Ang., 28cm)
00857987006897PBC220-1B (Medium Light C Applier, 20 cm)
00857987006880PBB236-1 (36cm Bayonet Applier for SLS Medium Clips, Vitalitec Supplied Jaws)
00857987006873PBB234-1 (Bayonet applier for Medium Clips, 34.1cm length, FSP0337)
00857987006866PBB220-1 (20cm Bayonet Applier for SLS Medium Clips, Vitalitec Supplied Jaws)
00857987006859PB228-EB (Medium Light Applier, FS, 28cm)
00857987006842PB228-E (Medium Clip Applier 28cm blue (E-Model))
00857987006835PB228-1B (Medium Clip Applier, 28cm Length Vitalitec Part Number and Logo)
00857987006828PB220-E (20cm Applier, Medium 9 Clip Cartridge)
00857987006811PB220-1B (Applier, Medium Clips, 20cm Length - Vitalitec Logo)
00857987006804PB215-E (Medium Clip Applier, 15cm, E Etched)
00857987006798PB215-1B (Medium Applier, 15cm Length - Vitalitec Logo Prt Number PB215-1)
00857987006781PVC328-E (Med/Large Applier, 28cm)
00857987006774PVC328-1B (Med/Lrg 28cm Applier, Angled, Vitalitec Logo and Part Number)
00857987006767PVC320-E (Medium Large C Applier, 20cm)
00857987006750PV328-E (Med/Large, 28cm (E-Model))
00857987006743PV328-1B (Applier- Med/Lrg Clips- 28cm Length, Vitalitec Logo and Prt Nr. PV328-1)
00857987006736PV320-E (Medium Large Applier, 20cm LOT#)
00857987006729PV320-1B (20cm Med/Lrg Applier, Vitalitec Logo LOT#)
00857987006712POE428-1B (Large Ethicon Style 28cm Applier)
00857987006705POE420-1E (Large, 20cm Ethicon Style Applier, Orange Ring Handles)
00857987006699POC428-E (Large Curved Clip Applier, 28cm E Etched)
00857987006682POC428-1B (Applier, Large Clips, 28cm Length- Angled VITALITEC LOGO)
00857987006675POC420-E (Large C Applier, 20cm)
00857987006668POC419-1B (large 19cm Applier, Angled, Vitalitec Logo and part Number)
00857987006651POC419-1 (Large Applier, 19cm Angled)
00857987006644PO428-E (Large Clip Applier, 28cm E Etched)
00857987006637PO428-1B (Applier-Large Clips- 28cm Length, Vitalitec Logo and Prt NR. PO428-1)
00857987006620PO420-E (Large Applier 20cm)
00857987006613PO420-1B (Large 20cm applier)
00857987006606PO419-E (Large Clip Applier, 19cm (E-Model))
00857987006590PO419-B (Large Clip Applier, 19cm
00857987006583LCA-5mm (Lap Appliers - 5mm) - Other
00857987006576LCASLS-3/20 (5mm Lap Applier Medium Clips, 20cm working length, 20 deg jaw angle)
00857987006569LCASLS-120BR (Lap Applier- Small Clips, 20cm Length ( 8"))
00857987006552LCA-0533M-22 (5mm x 22cm special Lap Applier, for Med Clips, Needs 6.5mm Trocar)
00857987006545LCA-0533 S (33 cm Lap Applier for Small Clips)
00857987006538LCA-0533 MS (33 cm Lap Applier for Sm/Med Clips)
00857987006521LCA-0533 M (33 cm Lap Applier for Medium Clips)
00857987006514LCA-0525 S (25 cm Lap Applier for Small Clips)
00857987006507LCA-0525 MS (25 cm Lap Applier for Sm/Med Clips)

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