FDA.reportPublic FDA data

Dermapac, Inc.

Primary DI
10810102270235
Brand
Dermapac, Inc.
Company
Dermapac Inc.
Model
5008
Device description
"1/2"" Packing 1/2"" x 36"" folded in plastic bag"
Published
2022-09-12
Public version status
Update
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
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810102270235PrimaryGS10
00810102270238Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010227023510810102270235
00810102270238008101022702388101022702380810102270238

GMDN Terms#

Term, Definition table
TermDefinition
Gauze strip, antimicrobialA thin length of woven material (e.g., cotton, cellulose) that is impregnated with an antimicrobial agent (e.g., iodoform) and primarily designed to pack draining wounds to absorb exudates. It may be soaked with other medication (not included) before application. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
796088466
Device count
100
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
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
10810102270136Dermapac, Inc.2080-B2022-09-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10197106760994CARDINAL HEALTHCardinal Health 200, LLCGDY2025-01-29
10080196031313MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-01-16
10080196743926MEDLINEMEDLINE INDUSTRIES, INC.GDY2024-10-15
10326053119504Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119511Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119528Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119535Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119542Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119559Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119566Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119573Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
10326053119580Regard™Resource Optimization & Innovation, L.L.C.GDY2023-08-09
08600036785272USMEDCOUS MEDCO INCGDY2023-07-14
08600036785340USMEDCOUS MEDCO INCGDY2023-07-14
08600036785418USMEDCOUS MEDCO INCGDY2023-07-14
08600036785586USMEDCOUS MEDCO INCGDY2023-07-14
08600036785654USMEDCOUS MEDCO INCGDY2023-07-14
10197106046968CARDINAL HEALTHCardinal Health 200, LLCGDY2023-07-12
10192253050288KerlixCardinal Health 200, LLCGDY2023-03-24
10665973000012DukalDukal LLCGDY2022-12-06
10665973000029DukalDukal LLCGDY2022-12-06
10665973000036DukalDukal LLCGDY2022-12-06
10665973000050DukalDukal LLCGDY2022-12-06
10665973000067DukalDukal LLCGDY2022-12-06
10665973000081DukalDukal LLCGDY2022-12-06
10665973000098DukalDukal LLCGDY2022-12-06
10665973000166DukalDukal LLCGDY2022-12-06