FDA.reportPublic FDA data

GAUZE / SPONGE, NONRESORBABLE FOR EXTERNAL USE

Primary DI
00860009716148
Brand
GAUZE / SPONGE, NONRESORBABLE FOR EXTERNAL USE
Company
Jhk, Inc.
Model
0551, 0552, 0553, 0572, 0573, 0802, 0803, 0804, 08
Published
2023-07-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00860009716148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009716148008600097161488600097161480860009716148

GMDN Terms#

Term, Definition table
TermDefinition
Woven gauze roll/sheetA device in the form of a long length of stretchable, absorbent, woven material (e.g., cotton, cellulose), wound into a roll or folded, and typically designed for a variety of applications (non-dedicated) such as a primary wound dressing, dressing retention, and 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
867236309
Device count
1
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009716162PACK, HOT OR COLD, DISPOSABLE0912, 0922, 0910, 0920, 0925, 09272023-07-28
00860009716100ELASTIC BANDAGE0314, 03932023-07-28
00860009716124SPRAY / PUMP0651, 0681, 0671, 0695, 0661, 0641, 06312023-07-28
00860009716186TAPE AND BANDAGE, ADHESIVE0505, 0535, 05752023-07-28
00860009716179ELASTIC BANDAGE0314, 03932023-07-28
00860009716117EXTRACTOR, SPLINTER REMOVER15242023-07-28
00860009716155SPRAY / PUMP0651, 0681, 0671, 0695, 0661, 0641, 06312023-07-28
00860009716131SCALPEL, ONE-PIECE1512, 1510, 15152023-07-28
00860009716193TAPE AND BANDAGE, ADHESIVE0505, 0535, 05752023-07-28

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Primary DI, Brand, Company table
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