FDA.reportPublic FDA data

Krinkle Super Sponges

Primary DI
00616784316321
Brand
Krinkle Super Sponges
Company
DYNAREX CORPORATION
Model
3163
Device description
Krinkle Super Sponges, Sterile, 2's, 6"x6.75"
Published
2021-06-21
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
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00616784316321PackageGS120In Commercial Distribution
00616784316338PackageGS120In Commercial Distribution
00616784316314PrimaryGS10
00616784316307Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784316321006167843163216167843163210616784316321
00616784316338006167843163386167843163380616784316338
00616784316314006167843163146167843163140616784316314
00616784316307006167843163076167843163070616784316307

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll, sterileA sterile device in the form of a long strip of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, injury padding and compression. It is not a dedicated pressure dressing and does not include latex. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
2
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
00616784245119SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24512026-10-01
00616784245218SafeTouch Sterile Latex Examination Gloves, Powder-Free, Cuffed, Ambidextrous24522026-10-01
00616784316925Cotton Balls, Large31692026-10-01
00616784317021Cotton Balls, Medium31702026-10-01
00616784671628SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrou67162026-09-30
00616784671727SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67172026-09-30
00616784671826SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67182026-09-30
00616784671925SafeTouch Aloetex Latex Examination Gloves, With Aloe, Powder-Free, Ambidextrous67192026-09-30
00840117346147Resp-O2 M24 Oxygen E-Cylinder, With CGA 870 Toggle Valve, 4.55 L36390-TBULK2026-09-28
00840117346154Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Toggle Valve36391-TBULK2026-09-28
00840117346239Resp-O2 M15 Oxygen Standard D-Cylinder, With CGA 870 Post Valve36391-PBULK2026-09-28
00840117320987Resp-O2 Suction Canister Rings, Compatible With 800 cc and 1200 cc Canister324092026-09-25
00840117352735dmecare Solutions Folding Beside Commode103702021-04-22
00840117352742dmecare Solutions Elongated Folding Bedside Commode103712021-04-22
00840117308855Resp-O2 Dry Bubble Humidifier, 6 PSI (Home Use), 400 mL342212022-05-11
00616784431321Junior Tongue Depressors, 5 1/2" (14.0 cm)43132021-09-01
00616784431420Senior Tongue Depressors, 6" (15.2 cm)43142021-09-01
00616784435213Gait Belt, Natural Colors, Metal Buckle, 60" x 2"43522021-09-01
00616784435312Gait Belt, Multicolor, Metal Buckle, 60" x 2"43532021-09-01
00616784435411Gait Belt, Multicolor, Wipeable Plastic Buckle, 60" x 2"43542021-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
G242YCBJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-12
G242YCAYMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCCCMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCETMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCADMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAKMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCASMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBOMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCDAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCABMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCACMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAEMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05