FDA.reportPublic FDA data

Dermapac, Inc.

Primary DI
00810102271044
Brand
Dermapac, Inc.
Company
Dermapac Inc.
Model
7516
Device description
5/16" Rubber Bands 10/pk
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
ECIBand, Elastic, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECIBand, Elastic, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810102271041PrimaryGS10
00810102271044Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081010227104110810102271041
00810102271044008101022710448101022710440810102271044

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, single-useA collection of various sterile dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. 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
25
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00371347021035Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021042Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021059Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021066Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021073Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021080Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021097Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021103Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021110Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021127Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021134Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021141Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021158Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021165Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021172Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021189Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021196Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021202Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021219Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
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00371347021240Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021257Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021264Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021271Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021288Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021295Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021301Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15
00371347021318Advance Dental ProductsThe Atlanta Dental Supply CompanyECI2026-01-15