FDA.reportPublic FDA data

Dermacea

Primary DI
20884527020963
Brand
Dermacea
Company
Cardinal Health, Inc.
Model
441123
Catalog number
441123
Device description
Gauze Roll,3 Ply
Published
2018-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
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
20884527020963PackageGS196In Commercial Distribution
10884527020966PrimaryGS10
30884527020960Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2088452702096320884527020963
1088452702096610884527020966
3088452702096030884527020960

GMDN Terms#

Term, Definition table
TermDefinition
Lumbar interspinous decompression instrument set, reusableA collection of surgical instruments and devices intended to be used for the implantation of an interspinous process decompression (IPD) implant that is inserted between two adjacent lumbar spinous processes during a minimally-invasive procedure to decompress neural structures; this is typically to treat a patient suffering from symptomatic degenerative lumbar spinal stenosis (DLSS). It typically consists of a tray, dedicated dilators, a sizing instrument, a spacer (the implant) insertion instrument, implant holders, and a torque-limiting screwdriver. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Width3Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00This side up;

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080935429
Device count
12
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
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
10884521190948Kangaroo384500W384500W2017-09-12
10884521190894Kangaroo3844003844002017-08-02
10884521544475Wings67093670932018-06-27
20884521544489Wings67095670952018-06-27
10884521023284Monoject8507SA8507SA2016-09-24
10884521208742Devon31145892311458922018-06-29
20884521154244Monoject8985PG2Y8985PG2Y2017-01-06
20884521513423Kendall8618RC8618RC2017-05-27
20884521706177Kangaroo388105E388105E2017-04-20
20884527016034Devon31145926311459262018-06-29
30884521022533Monoject8997SPG28997SPG22016-09-24
30884521022557Monoject8998SPG28998SPG22016-09-24
30884527016048Devon31145942311459422018-06-29
40884521022417Monoject8932PG28932PG22016-09-24
10884521019119SharpSafety8556H8556H2018-06-27
20884527000125Argyle888825737888882573782016-09-24
20884527000132Argyle888825738688882573862016-09-24
10884527019854Argyle888850103188885010312016-09-24
10884527019922Argyle888850200588885020052016-09-24
10884527019847Argyle888850102388885010232016-09-24

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