FDA.reportPublic FDA data

Dukal

Primary DI
20665973032478
Brand
Dukal
Company
Dukal LLC
Model
UPP-223
Catalog number
UPP-223
Device description
"Sterilization Pouches - 2-1/4"" x 3-3/4"""
Published
2025-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRGWrap, sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162258000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162258000Self Sealing Sterilization PouchesTianchang Jiarui Packaging Material Co., Ltd.2017-04-28FRG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30665973032475PackageGS130In Commercial Distribution
20665973032478PrimaryGS10
00665973032474Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3066597303247530665973032475
2066597303247820665973032478
00665973032474006659730324746659730324740665973032474

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
200
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
20665973032423Dukal108775910877592026-10-14
20665973032430Dukal108776010877602026-10-14
10665973027347Dukal27602276022022-12-06
10665973032198RENCURARCCA66RCCA662024-11-04
10665973032259RENCURARCCS48RCCS482024-11-04
10665973029488UnipackUGC-6600-LUGC-6600-L2022-12-06
10665973029495UnipackUGC-6600-MUGC-6600-M2022-12-06
10665973029501UnipackUGC-6600-SUGC-6600-S2022-12-06
10665973029518UnipackUGC-6600-XLUGC-6600-XL2022-12-06
10665973029525UnipackUGC-6600-XXLUGC-6600-XXL2022-12-06
10665973029532UnipackUGC-6601-LUGC-6601-L2022-12-06
10665973029549UnipackUGC-6601-MUGC-6601-M2022-12-06
10665973029556UnipackUGC-6601-SUGC-6601-S2022-12-06
10665973029563UnipackUGC-6601-XLUGC-6601-XL2022-12-06
10665973029570UnipackUGC-6601-XXLUGC-6601-XXL2022-12-06
10665973029587UnipackUGC-6602-LUGC-6602-L2022-12-06
10665973029594UnipackUGC-6602-MUGC-6602-M2022-12-06
10665973029600UnipackUGC-6602-SUGC-6602-S2022-12-06
10665973029617UnipackUGC-6602-XLUGC-6602-XL2022-12-06
10665973029624UnipackUGC-6602-XXLUGC-6602-XXL2022-12-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850091155109Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155116Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155123Benchmark Sterilization PouchBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155130Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155147Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155154Benchmark Sterilization RollBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155161Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155178Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155185Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
00850091155192Benchmark Sterilzation WrapBENCHMARK MEDICAL INSTRUMENTS INC.FRG2026-10-30
06954454006672COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006689COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006696COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006702COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006719COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006726COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006733COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454006740COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
06954454013984COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-30
08404535038446Brasseler USAPeter Brasseler Holdings, LLCFRG2026-10-30
06954454006849COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006856COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006863COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006870COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006887COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006894COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006900COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006917COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454006924COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23
06954454016244COTISENHuanghua Promisee Dental Co., Ltd.FRG2026-10-23