Dermapac, Inc.

GUDID 00810102270436

Danbury Rounds (OR gauze sponges 5/pk 2pks/pouch)

Dermapac Inc.

Radiopaque woven surgical sponge
Primary Device ID00810102270436
NIH Device Record Key545a3531-8b7f-4e57-a465-354f76e449f9
Commercial Distribution StatusIn Commercial Distribution
Brand NameDermapac, Inc.
Version Model Number5371
Company DUNS796088466
Company NameDermapac Inc.
Device Count125
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com
Phone203-924-7148
Emaildermapac@msn.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810102270436 [Unit of Use]
GS110810102270433 [Primary]

FDA Product Code

GDYGauze/Sponge, Internal, X-Ray Detectable

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-20
Device Publish Date2022-09-12

On-Brand Devices [Dermapac, Inc.]

00810102271563Sponge Forcep - 7"
00810102271808Open Thoracentesis Set
00810102271792Open Paracentesis Set
00810102271785Closed Thoracostomy Tray
00810102271778Delivery Set
00810102271761Tracheostomy Tray
00810102271754Tracheostomy Tray
00810102271747Cut Down Set
00810102271730ER Hand Tray
00810102271723Curved Kelly Forceps
00810102271716Mosquito Forceps 5"
00810102271709Magill Forcep 9-3/4"
00810102271693Hartman Alligator Froceps 3-1/2"
00810102271686Dressing Shears
00810102271679Vienna Nasal Specula medium
00810102271662Vienna Nasal Specula small
00810102271655Dressing Forceps 8" serrated
00810102271648Russian Forcep 8"
00810102271631Ring Cutter
00810102271624Blakesley Nasal Forcep
00810102271617Tissue Forcep 4-1/2 1x2Teeth
00810102271600Rochester-Pean Forceps Str 8"
00810102271594Foerster Sponge Forcep
00810102271587Micro Aural Cup Forcep Cvd
00810102271570Micro Aural Cup Forcep Str
00810102271556Stitch Scissor - small
00810102271549Mayo Curved Scissor 5.5"
00810102271532Admin Set
00810102271525Bayonett Forceps 6.5"
00810102271518Bayonett Forceps 5.5"
00810102271501Tracheotomy Tray
00810102271495Arthroscopy Dressing Pack
00810102271488Full Head Dressing
00810102271471Safety Pins 1/pk
00810102271464Safety Pins 1/pk
00810102271457Safety Pins 2/pk
00810102271440ER Delivery Set
00810102271433Disposable Laceration Tray
00810102271426Dobie Pads
00810102271419#32 Latex Free Bands 1/pk
00810102271402#16 Rubber Bands 1/pk
00810102271396Weck Blades 1/pk
00810102271389Weck Blades 5/pk
00810102271372OPTH Eye Bag 7" x 12" 2/pk
00810102271365Sterilization Pouch 14" x 18"
00810102271358Retention Booties ID 1/8" wall 1/32" OD 3/16" 3" long 4/pk
00810102271341Silicone Tubing 1/4" x 3/8" 6" long 1/pk
00810102271334Silicone Tubing 1/4" x 3/8" 6" long 2/pk
00810102271327Toothpicks 4/pk
00810102271310Thoracostomy Tray

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