FDA.report

Dermapac, Inc.

Primary DI
00810102271303
Brand
Dermapac, Inc.
Company
Dermapac Inc.
Model
8692
Device description
Silicone Tubing 3/16" x 5"/16" 2/pk NON Sterile
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
BYXTubing, Pressure And Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
BYXTubing, Pressure And AccessoriesAnesthesiology1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10810102271300PrimaryGS10
00810102271303Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010227130010810102271300
00810102271303008101022713038101022713030810102271303

GMDN Terms

TermDefinition
Suction/irrigation tubing, single-useA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a single-use device.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
203-924-7148dermapac@msn.com

Regulatory Flags

DUNS number
796088466
Device count
50
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810102270009Dermapac, Inc.18032022-09-12
00810102270016Dermapac, Inc.18042022-09-12
00810102270023Dermapac, Inc.18052022-09-12
00810102270030Dermapac, Inc.18092022-09-12
00810102270047Dermapac, Inc.18102022-09-12
00810102270054Dermapac, Inc.18122022-09-12
00810102270061Dermapac, Inc.18142022-09-12
00810102270078Dermapac, Inc.18152022-09-12
00810102270085Dermapac, Inc.18322022-09-12
00810102270092Dermapac, Inc.18602022-09-12
00810102270108Dermapac, Inc.20342022-09-12
00810102270115Dermapac, Inc.20362022-09-12
00810102270122Dermapac, Inc.20382022-09-12
00810102270139Dermapac, Inc.2080-B2022-09-12
00810102270146Dermapac, Inc.20812022-09-12
00810102270153Dermapac, Inc.20872022-09-12
00810102270160Dermapac, Inc.21392022-09-12
00810102270177Dermapac, Inc.21402022-09-12
00810102270184Dermapac, Inc.21422022-09-12
00810102270191Dermapac, Inc.50032022-09-12

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