FDA.reportPublic FDA data

Dermapac, Inc.

Primary DI
00810102270238
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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
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 sterile 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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
796088466
Device count
100
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
false

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
00199536924000BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924024BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924031BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
00199536924055BluelineTransparent Supply Solutions Ltd.GDY2026-08-07
10198956239692CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
00850049994866SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994873SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994880SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994897SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994903SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994910SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994927SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994934SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994941SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994958SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994965SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994972SynterventionZien Medical Technologies, LLCGDY2025-09-26
00850049994996SynterventionZien Medical Technologies, LLCGDY2025-09-23
00850049994989SynterventionZien Medical Technologies, LLCGDY2025-09-22
07613327465853SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
10080196717811MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-04-25
10810178830005Tally Surgical SolutionTally Surgical, Inc.GDY2025-02-18
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