FDA.reportPublic FDA data

Dermapac, Inc.

Primary DI
10810102271393
Brand
Dermapac, Inc.
Company
Dermapac Inc.
Model
8808
Device description
Weck Blades 1/pk
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GESBlade, Scalpel

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GESBlade, ScalpelGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810102271393PrimaryGS10
00810102271396Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010227139310810102271393
00810102271396008101022713968101022713960810102271396

GMDN Terms#

Term, Definition table
TermDefinition
Razor bladeA device with an extremely sharp cutting edge intended to be inserted into a reusable razor to enable hair removal. It comes in various designs, traditionally with two cutting edges (one on either side of the blade's width). Though this device is reusable and designed to be used until blunted, it is for single-patient use to reduce the risk of cross-infection. Some types can be purposely broken into smaller segments to be used like a scalpel to cut tissue, e.g., during certain ophthalmologic surgical procedures. This is a reusable device.

Contacts#

Phone, Email table
PhoneEmail
203-924-7148dermapac@msn.com

Regulatory Flags#

DUNS number
796088466
Device count
25
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810102271560Dermapac, Inc.99602022-07-12
10810102270112Dermapac, Inc.20362022-09-12
10810102270150Dermapac, Inc.20872022-09-12
10810102270235Dermapac, Inc.50082022-09-12
10810102270242Dermapac, Inc.5008-A2022-09-12
10810102271546Dermapac, Inc.99102022-09-12
10810102271553Dermapac, Inc.99112022-09-12
10810102271683Dermapac, Inc.99792022-09-12
10810102270006Dermapac, Inc.18032022-09-12
10810102270013Dermapac, Inc.18042022-09-12
10810102270020Dermapac, Inc.18052022-09-12
10810102270037Dermapac, Inc.18092022-09-12
10810102270044Dermapac, Inc.18102022-09-12
10810102270051Dermapac, Inc.18122022-09-12
10810102270068Dermapac, Inc.18142022-09-12
10810102270075Dermapac, Inc.18152022-09-12
10810102270082Dermapac, Inc.18322022-09-12
10810102270099Dermapac, Inc.18602022-09-12
10810102270105Dermapac, Inc.20342022-09-12
10810102270129Dermapac, Inc.20382022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810055255184Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255191Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255207Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255214Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255238Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255245Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255252Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255269Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255276Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255283Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255290Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255313Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255320Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255337Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255368Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255382Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255429Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255436Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255443Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255450Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255467Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255474Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255511Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255528Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255535Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255542Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255559Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255566Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255580Surgical DesignSurgical Design, Inc.GES2026-09-26
00810055255597Surgical DesignSurgical Design, Inc.GES2026-09-26